Cleared Traditional

AMUKIN 50% - AIRSPRAY(R) (K885037) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K885037 · Bernard J. Cooney, P.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.