Cleared Traditional

K884061 - ADD-A-CATH

K884061 is an FDA 510(k) clearance for ADD-A-CATH, manufactured by Femcare , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K884061 · Femcare , Ltd. · Gastroenterology & Urology device
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Oct 1988
Decision
29d
Days
Class 2
Risk

K884061 is an FDA 510(k) clearance for the ADD-A-CATH. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Femcare , Ltd. (Nottingham, England, GB). The FDA issued a Cleared decision on October 25, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Femcare , Ltd. devices

FDA 510(k) Submission Details - K884061

510(k) Number K884061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date October 25, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 15
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K884061.
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · Bivona Medical Technologies · May 1990
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · Van-Tec, Inc. · Mar 1987
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET
K870556 · Van-Tec, Inc. · Mar 1987
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · Cook Urological, Inc. · Oct 1986