Cleared Traditional

K885037 - AMUKIN 50% - AIRSPRAY

K885037 is an FDA 510(k) clearance for AMUKIN 50% - AIRSPRAY, manufactured by Bernard J. Cooney, P.A.. The device is a Class 2 Gastroenterology & Urology device with product code FKO cleared through the Traditional 510(k) pathway after a 683-day FDA review.

K885037 · Bernard J. Cooney, P.A. · Gastroenterology & Urology device
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Oct 1990
Decision
683d
Days
Class 2
Risk

K885037 is an FDA 510(k) clearance for the AMUKIN 50% - AIRSPRAY(R). Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Bernard J. Cooney, P.A. (Chevy Chase, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 683 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Bernard J. Cooney, P.A. devices

FDA 510(k) Submission Details - K885037

510(k) Number K885037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date October 19, 1990
Days to Decision 683 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
553d slower than avg
Panel avg: 130d · This submission: 683d
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 10
Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K885037.
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · Quinton, Inc. · Dec 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · Quinton, Inc. · May 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · Quinton, Inc. · Feb 1987
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155 · Medical Components, Inc. · Feb 1986
CAPD STAGED CONNECTOR
K845041 · Abbott Laboratories · Feb 1985
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · American Pharmaseal Div. Ahsc · Dec 1981