BETA
Turkish manufacturer of single-use medical devices, including syringes, needles, infusion products and feeding consumables, with documented U.S. 510(k) clearances for specified syringes and needles.
Set Medikal is a privately held manufacturer of disposable medical devices founded in 1977 and headquartered in Istanbul, Türkiye. Its production site is in Esenyurt, Istanbul. The company markets syringes, needles, diabetes consumables, infusion and IV-access products, feeding devices and catheters to healthcare and distribution customers in domestic and export markets.
Two FDA 510(k) decisions were verified: K201284, cleared December 14, 2020, covers specified hypodermic syringes, insulin syringes and hypodermic needles; K210200, cleared May 14, 2021, adds specified 1 mL hypodermic syringes. These are product-specific clearances, not blanket FDA approval of the catalog. The summaries describe standards-based performance, sterility and biocompatibility evidence.
Air-Tite Products currently lists SET inject syringes and publicly identifies a partnership with Set Medikal, supporting a documented U.S. sales channel. Radiometer’s older blood-gas syringe distribution relationship is historical: its announcement was updated to say it stopped selling the product in September 2024. Set Medikal reports completion of CE MDR certification in 2025; certificate scope and current revenue were not independently verified.
Two unique 510(k) decisions support specified SET hypodermic/insulin syringe and needle configurations; the shared syringe decision is counted once. Pen needles, IV-access products and feeding syringes in the broader catalog do not inherit those clearances. [10][2][3][23][24][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [7][5]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
Disposable three-part syringe family; cleared configurations are specified in K201284 and the 1 mL addition K210200. [22][10][11][14]
FDA-clearedCurrent manufacturer catalog and U.S. SET inject distributor listings; confirm individual SKU.
Selected sterile fixed-needle insulin syringes are included in K201284; broader marketed variants require separate matching. [25][10]
FDA-clearedListed in current manufacturer portfolio; U.S. SKU availability not independently confirmed.
Sterile single-lumen needles for use with syringes and injection devices; selected configurations covered by K201284. [23][10]
FDA-clearedListed in current manufacturer portfolio; U.S. SKU availability not independently confirmed.
Manufacturer lists pen needles in multiple gauges and lengths, separately from fixed-needle insulin syringes. [24]
Marketed · regulatory scope variesMarketed in current company catalog; market-specific availability should be confirmed.
Portfolio includes IV cannulas, infusion sets, extension lines, flow regulators and three-way stopcocks. [27]
Marketed · regulatory scope variesMarketed in current company catalog; U.S. availability not established for this grouped portfolio.
Catalog includes oral-tip feeding syringes and SET ENFit enteral feeding syringes. [26]
Marketed · regulatory scope variesMarketed in current company catalog; U.S. authorization and SKU availability not established.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Air-Tite Products [14][16] | United States — documented sales channel | SET inject Luer Slip and Luer Lock three-part syringes |
Sources checked October 17, 2026.
Company LinkedIn states CE MDR certification completed in 2025. Certificate scope, notified body and validity not independently inspected. [15]
Radiometer updated its announcement in September 2024 to state that it no longer sells SET Medikal syringes. This does not establish worldwide discontinuation by Set Medikal. [17]
Radiometer’s regional announcement described distribution of SET blood-gas syringes. This relationship is historical; a later notice ended sales. [17]
Special 510(k) documents addition of specified 1 mL hypodermic syringes with or without needles. [13]
One 510(k) decision covers specified hypodermic syringes, insulin syringes and hypodermic needles. [12]
Established in Istanbul as a producer of disposable medical devices. [19]
Accessed 10/20/2026