Cleared Traditional

K821680 - HOLLISTER CATHETER ACCESS. PORT

K821680 is an FDA 510(k) clearance for HOLLISTER CATHETER ACCESS. PORT, 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 16-day FDA review.

K821680 · Hollister, Inc. · Gastroenterology & Urology device
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Jun 1982
Decision
16d
Days
Class 1
Risk

K821680 is an FDA 510(k) clearance for the HOLLISTER CATHETER ACCESS. PORT. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 16 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 - K821680

510(k) Number K821680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date June 24, 1982
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
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 K821680.
ACTIVE LIFE
K833625 · Convatec, A Division of E.R. Squibb & Sons · Nov 1983
SUR-FIT FLEXIBLE
K830945 · Convatec, A Division of E.R. Squibb & Sons · Apr 1983
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982
FECAL INCONTINENCE COLLATOR
K813270 · Hollister, Inc. · Dec 1981
TWO PIECE OSTOMY SYSTEM
K813269 · Hollister, Inc. · Dec 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp. · Nov 1981