
CompactCath intermittent catheters ↗
Pocket-format, pre-lubricated intermittent urinary catheters with a protective handling sheath. [4][8][9]
FDA-clearedListed by the company; configurations and market availability vary.

Developer and commercializer of compact intermittent urinary catheters and related urinary-care devices.
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.
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.
Latest recorded source review: 2026-10-28.
Documented commercial product families.

Pocket-format, pre-lubricated intermittent urinary catheters with a protective handling sheath. [4][8][9]
FDA-clearedListed by the company; configurations and market availability vary.

Conventional-length pre-lubricated urinary catheters with a protective sheath and straight or coudé options. [5][7]
FDA-clearedListed by the company; configurations and market availability vary.

Female external urine-collection catheter designed to connect to compatible suction equipment. [6]
Marketed · regulatory scope variesListed by the company; configurations and market availability vary.
FDA cleared the CompactCath intermittent urinary catheter under K140945. [9]
Accessed 10/28/2026