Cleared Traditional

K905422 - PVC ROUND WOUND DRAINS

K905422 is an FDA 510(k) clearance for PVC ROUND WOUND DRAINS, manufactured by Axiom Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K905422 · Axiom Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
69d
Days
Class 1
Risk

K905422 is an FDA 510(k) clearance for the PVC ROUND WOUND DRAINS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Paramount, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K905422

510(k) Number K905422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date February 11, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 38
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K905422.
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739 · Hollister, Inc. · Aug 1992
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245 · Surgical Technologies, Inc. · Apr 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
DISPOSABLE FLUID COLLECTION BAG
K904133 · Axiom Medical, Inc. · Oct 1990
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · Arrow Intl., Inc. · Dec 1989
THORACIC CATHETERS
K883474 · Westmark, Sterile Packing Systems, Inc. (Sps) · Sep 1988