Cleared Traditional

K802954 - DRESSING CHANGE TRAY-MEDIUM

K802954 is an FDA 510(k) clearance for DRESSING CHANGE TRAY-MEDIUM, manufactured by Associated Medical Products Co.. The device is a Class 2 Gastroenterology & Urology device with product code FKO cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K802954 · Associated Medical Products Co. · Gastroenterology & Urology device
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Dec 1980
Decision
27d
Days
Class 2
Risk

K802954 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY-MEDIUM. Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Associated Medical Products Co. devices

FDA 510(k) Submission Details - K802954

510(k) Number K802954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1980
Decision Date December 17, 1980
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKO Device Classification - Class 2, Special Controls

Product Code FKO Catheter, Peritoneal Dialysis, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKO Catheter, Peritoneal Dialysis, Single Use

All 9
Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K802954.
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · American Pharmaseal Div. Ahsc · Dec 1981
NON-STERILE SHADOW-STRIPE CATHETER
K812717 · Quinton, Inc. · Oct 1981
QUINTON CATHETER FINGER GRIP
K811266 · Quinton, Inc. · Jun 1981
CATHETER, PERITONEAL DIALYSIS
K760544 · Travenol Laboratories, S.A. · Oct 1976