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Companies / CompactCath
Medical device company profile

CompactCath

Developer and commercializer of compact intermittent urinary catheters and related urinary-care devices.

ManufacturerUrology & Renal CareUrology
Headquarters🇺🇸Palo Alto, California, United States
Founded2012
Commercial statusCommercially availableDocumented marketed products; availability varies by product and country.
Employees11–50 [2]LinkedIn company-size range · Checked 2026-10-27
Estimated revenueNot confirmed
Official websitewww.compactcath.com ↗

Company overview

CompactCath, Inc. develops and commercializes urinary-care devices for people who need catheterization. Its CompactCath and OneCath products are intermittent catheters intended to drain urine from the bladder.

The company traces its design origins to a Stanford interdisciplinary team. Its portfolio combines compact pocket-format catheters, conventional-length catheters and the SecureSoft female external catheter. Product availability is documented through its official storefront and distribution channels.

This profile covers selected branded device families. FDA clearances for intermittent catheters do not automatically apply to every product or model sold in the store.

[1][2]

Leadership

1 people
Daniel Wei-Chen HongCo-founder & Chief Medical Officer [3]

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA records document three intermittent-catheter clearances naming CompactCath, Inc.: K140945 (2014), K160858 (2016) and K180738 (2018). K180738 explicitly names both CompactCath and OneCath; it is counted once. [7][8][9]

SecureSoft is documented as a marketed external urine-collection product. Its device-specific U.S. regulatory basis has not been established here and should not be inferred from the intermittent-catheter clearances. [6]

Applicant-name recall and PMA searches were performed, but alias and product coverage remain incomplete.

Regulatory snapshot How to read this snapshot

U.S. FDA
3+
510(k) clearances
—
De Novo grants
—
PMA approvals
—
Recall events

Latest recorded source review: 2026-10-28.

Commercial portfolio snapshot

Documented commercial product families.

CompactCath intermittent catheters — official product-family image
Image: CompactCath
Intermittent urinary catheters

CompactCath intermittent catheters ↗

Pocket-format, pre-lubricated intermittent urinary catheters with a protective handling sheath. [4][8][9]

FDA-cleared

Listed by the company; configurations and market availability vary.

OneCath Lubricated — official product-family image
Image: CompactCath
Intermittent urinary catheters

OneCath Lubricated ↗

Conventional-length pre-lubricated urinary catheters with a protective sheath and straight or coudé options. [5][7]

FDA-cleared

Listed by the company; configurations and market availability vary.

SecureSoft female external catheter — official product-family image
Image: CompactCath
External urinary catheter

SecureSoft female external catheter ↗

Female external urine-collection catheter designed to connect to compatible suction equipment. [6]

Marketed · regulatory scope varies

Listed by the company; configurations and market availability vary.

Activity & Milestones

1 events
2014-08-22 · Regulatory

First documented CompactCath 510(k) clearance

FDA cleared the CompactCath intermittent urinary catheter under K140945. [9]

9 Cited Sources

Accessed 10/28/2026

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