Cleared Traditional

K954959 - CAP-AID

K954959 is an FDA 510(k) clearance for CAP-AID, manufactured by Nebl, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FHA cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K954959 · Nebl, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
40d
Days
Class 1
Risk

K954959 is an FDA 510(k) clearance for the CAP-AID. Classified as Clamp, Penile (product code FHA), Class I - General Controls.

Submitted by Nebl, Inc. (Worcester, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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 Nebl, Inc. devices

FDA 510(k) Submission Details - K954959

510(k) Number K954959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date December 06, 1995
Days to Decision 40 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
91d faster than avg
Panel avg: 131d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

FHA Device Classification - Class 1, General Controls

Product Code FHA Clamp, Penile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FHA Clamp, Penile

All 8
Devices cleared under the same product code (FHA) and FDA review panel - the closest regulatory comparables to K954959.
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
K970308 · Mentor Urology, Inc. · Apr 1997
CAP-AID (IMPROVED)
K964580 · Nebel, Inc. · Jan 1997
U-TEX
K955810 · Laborie Medical Technologies, Ltd. · Jan 1996
WILLIAMS PENILE ANESTHETIC RETAINER
K896160 · Cook Urological, Inc. · Feb 1990
DACOMED EXTERNAL MALE CONTINENCE DEVICE
K885323 · Dacomed Corp. · Feb 1989
COOK-VPI CONTINENCE CUFF
K863227 · Cook Urological, Inc. · Feb 1987