Cleared Traditional

K103043 - COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103043 · Adapta Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
85d
Days
Class 2
Risk

K103043 is an FDA 510(k) clearance for the COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Adapta Medical, Inc. (Denver, US). The FDA issued a Cleared decision on January 7, 2011 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adapta Medical, Inc. devices

Submission Details

510(k) Number K103043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date January 07, 2011
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K103043.
LoFric Elle Pro
K260999 · Wellspect AB · Apr 2026
GentleCath Air for Men
K252943 · Convatec Limited · Apr 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · HR Healthcare · Mar 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · HR Healthcare · Jan 2026
Ready to use Nelaton Catheter
K251178 · Jamjoom Fullcare Corporation · Jan 2026
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
K251468 · Hollister Incorporated · Oct 2025