Cleared Special

K161445 - PerfIC Cath Gel S

K161445 is an FDA 510(k) clearance for PerfIC Cath Gel S, manufactured by Adapta Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Special 510(k) pathway after a 83-day FDA review.

K161445 · Adapta Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
83d
Days
Class 2
Risk

K161445 is an FDA 510(k) clearance for the PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Adapta Medical, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on August 16, 2016 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Adapta Medical, Inc. devices

FDA 510(k) Submission Details - K161445

510(k) Number K161445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2016
Decision Date August 16, 2016
Days to Decision 83 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K161445.
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
K180738 · Compactcath, Inc. · Jun 2018
Medline Catheter Specimen Collector
K172541 · Medline Industries, Inc. · Feb 2018
Magic3 Go Intermittent Urinary Catheter
K172247 · C.R. Bard, Inc. · Sep 2017
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · C.R. Bard, Inc. · Apr 2014