# K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

- Pathway: 510(k) (Special)
- Applicant: Adapta Medical, Inc.
- Decided: Aug 16, 2016 after 83 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003874 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103043: Colorado Catheter Sterilesure - New Name Perfic Cath, Adapta Medical, Inc. (2011) Summary page 4.
- K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,, Hangzhou Bever Medical Devices Co., Ltd. (2012) Summary page 4.

## Indications for use
The PerfIC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Source page: https://510kreport.com/device/K161445
Methodology: https://510kreport.com/methodology