Steam sterilizer
T-Edge 10 and T-Edge 11 ↗
Tabletop steam sterilizers. [29][31]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Companies / Tuttnauer
Medical device company profile
Tuttnauer
Manufacturer of autoclaves, washer-disinfectors and sterile-processing equipment for clinical and laboratory settings.
Medical Device ManufacturerGeneral Medical & Patient CareHospital Equipment & ConsumablesSterilization & Infection PreventionCommercial-stage
Company overview
Tuttnauer manufactures sterilization and infection-control equipment for medical, dental and laboratory customers. Its portfolio includes tabletop and freestanding autoclaves, washer-disinfectors and associated sterile-processing products.
Selected FDA records cover T-Edge and T-Top tabletop sterilizers and a named horizontal autoclave series. Those authorizations belong to specific models and configurations; neither the broader catalog nor third-party accessories are automatically covered by the same clearance.
Hagay Azani leads the global company, while Guy Lerner serves as president of Tuttnauer USA. The business combines manufacturing with international distributor and service networks. A reviewed open recall concerns specified Terragene-manufactured chemical indicators sold under several brands, including Tuttnauer, rather than Tuttnauer autoclaves.
Leadership
2 peopleHagay AzaniChief Executive Officer [30]
Guy LernerPresident, Tuttnauer USA [36]
Products & regulatory status How does MedTechIndex get this information?
Summary
Selected T-Edge, T-Top and horizontal sterilizer models have matched 510(k) decisions, including earlier horizontal-family records. The Terragene WTL198-0082 chemical-indicator recall concerns specified third-party accessory lots, not a blanket recall of Tuttnauer sterilizers. [29][3][9][28][1]
The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. Z-0836-2024 (2023-12-07; open, classified): Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. [25]
Regulatory snapshot How to read this snapshot
U.S. FDA- 6
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
Documented commercial product families.
Steam sterilizer
T-Top 10 and T-Top 11 ↗
Tabletop steam sterilizer models. [29][33]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Steam sterilizer
Horizontal autoclaves 4472, 5596, 6690 and 66120 ↗
Named horizontal steam sterilizer model series. [29][32]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Products with unconfirmed commercial availability
Third-party sterilization indicator
Terragene chemical indicator WTL198-0082 — scoped recall ↗
Terragene-manufactured indicator sold under Tuttnauer branding; historical affected lots only. [29]
Commercial availability not establishedCurrent availability of the recalled presentation not established.
Commercial development
Selected sterilizer models reviewed; third-party accessory recall preserved with original manufacturer and exact scope. [29]
36 Cited Sources
Accessed 10/20/2026
36 Cited Sources
Accessed 10/20/2026
[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[2] FDA K003470 — EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 ↗U.S. Food and Drug Administration · regulatory record
[3] FDA K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 ↗U.S. Food and Drug Administration · regulatory record
[4] FDA K032192 — PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V ↗U.S. Food and Drug Administration · regulatory record
[5] FDA K063711 — TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA ↗U.S. Food and Drug Administration · regulatory record
[6] FDA K090783 — TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE ↗U.S. Food and Drug Administration · regulatory record
[7] FDA K111736 — TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES ↗U.S. Food and Drug Administration · regulatory record
[8] FDA K143311 — Pre-vacuum Tabletop Autoclave ↗U.S. Food and Drug Administration · regulatory record
[9] FDA K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator ↗U.S. Food and Drug Administration · regulatory record
[10] FDA K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves ↗U.S. Food and Drug Administration · regulatory record
[11] FDA K213080 — T-Edge 10, T-Edge 11 ↗U.S. Food and Drug Administration · regulatory record
[12] FDA K221227 — Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 ↗U.S. Food and Drug Administration · regulatory record
[13] FDA K222608 — Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS ↗U.S. Food and Drug Administration · regulatory record
[14] FDA K232658 — T-Top 10 & T-Top T-Top 11 ↗U.S. Food and Drug Administration · regulatory record
[15] FDA K833837 — AMERICAN GOLD SERIES AUTOCLAVE ↗U.S. Food and Drug Administration · regulatory record
[16] FDA K850264 — TUTTNAUER PRE-VACUUM AUTOCLAVE ↗U.S. Food and Drug Administration · regulatory record
[17] FDA K920478 — TUTTNAUER LSI (AUTOMATIC) ↗U.S. Food and Drug Administration · regulatory record
[18] FDA K962282 — TUTTNAUER PREVACUUM TABLE AUTOCLAVE ↗U.S. Food and Drug Administration · regulatory record
[19] FDA K973550 — TUTTNAUER TABLE-TOP AUTOCLAVE ↗U.S. Food and Drug Administration · regulatory record
[20] FDA K990761 — TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE ↗U.S. Food and Drug Administration · regulatory record
[21] FDA K993856 — TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP ↗U.S. Food and Drug Administration · regulatory record
[22] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[23] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[24] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[25] FDA recall Z-0836-2024 — TERRAGENE S.A. ↗U.S. Food and Drug Administration · regulatory record
[26] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[27] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[28] Autoclave sterilizers, washer disinfectors, and other sterile processing products | Tuttnauer ↗Tuttnauer · company website
[29] Manufacturing and product scope ↗Tuttnauer · company website
[30] Current global CEO ↗Tuttnauer · company website
[31] FDA 510(k) K213080 ↗U.S. Food and Drug Administration · regulatory database
[32] FDA 510(k) K221227 ↗U.S. Food and Drug Administration · regulatory database
[33] FDA 510(k) K232658 ↗U.S. Food and Drug Administration · regulatory database
[34] FDA recall Z-0836-2024 ↗U.S. Food and Drug Administration · regulatory database
[35] Hiring source review ↗Tuttnauer · company website
[36] Tuttnauer USA and global leadership statement ↗Tuttnauer · company website