Cleared Traditional

K801442 - P-S SURGICAL DRAIN

K801442 is the FDA 510(k) clearance for P-S SURGICAL DRAIN by Pudenz-Schulte Medical Research Corp.. It is a Class 1 General & Plastic Surgery device (product code GCY) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K801442 · Pudenz-Schulte Medical Research Corp. · General & Plastic Surgery device
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Jul 1980
Decision
24d
Days
Class 1
Risk

K801442 is an FDA 510(k) clearance for the P-S SURGICAL DRAIN. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Walker, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K801442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1980
Decision Date July 14, 1980
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 38
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K801442.
SAF SINGLE-USE AEROSOL FILTER
K811203 · Sorensen Research · May 1981
SARNS MINI-SUCKER
K810416 · 3M Health Care, Sarns · Mar 1981
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · Edward Weck, Inc. · Aug 1980
P-S SUCTION RESERVOIR
K801443 · Pudenz-Schulte Medical Research Corp. · Jul 1980
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.
K801371 · Sherwood Medical Co. · Jun 1980
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
K801372 · Sherwood Medical Co. · Jun 1980