Cleared Traditional

K791525 - HOLLISTER KARAYA PASTE

K791525 is an FDA 510(k) clearance for HOLLISTER KARAYA PASTE, manufactured by Hollister, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K791525 · Hollister, Inc. · Gastroenterology & Urology device
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Oct 1979
Decision
77d
Days
Class 1
Risk

K791525 is an FDA 510(k) clearance for the HOLLISTER KARAYA PASTE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Walker, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K791525

510(k) Number K791525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date October 26, 1979
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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 - EXB Collector, Ostomy

All 68
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K791525.
STOMAHESIVE POWDER
K792382 · E. R. Squibb & Sons, Inc. · Dec 1979
BONGORT ODOR BARRIER DRAIN
K792381 · Howmedica Corp. · Dec 1979
FEATHER-LITE URINARY DIV. POUCH
K792139 · Howmedica Corp. · Nov 1979
HOLLISTER STOMA POUCH SKIN BARRIER
K791526 · Hollister, Inc. · Oct 1979
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535 · Hollister, Inc. · Oct 1979
HOLLISTER UROSTOMY POUCH
K791534 · Hollister, Inc. · Oct 1979