Cleared Traditional

K813377 - PS-ROUND SURG. DRAIN & CONNECTOR

K813377 is the FDA 510(k) clearance for PS-ROUND SURG. DRAIN & CONNECTOR 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 35-day FDA review.

K813377 · Pudenz-Schulte Medical Research Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
35d
Days
Class 1
Risk

K813377 is an FDA 510(k) clearance for the PS-ROUND SURG. DRAIN & CONNECTOR. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982 after a review of 35 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 K813377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date January 05, 1982
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 K813377.
STRYKER CONSTAVAC
K823284 · Stryker Corp. · Jan 1983
ARGYLE VAC-U-CARE 100CC SUCTION RESERV
K821563 · Sherwood Medical Co. · Jun 1982
P-S SUCTION RESERVIOR
K820474 · Pudenz-Schulte Medical Research Corp. · Mar 1982
DEPUY HEMODRAIN
K811557 · Depuy, Inc. · Jul 1981
SAF SINGLE-USE AEROSOL FILTER
K811203 · Sorensen Research · May 1981
SARNS MINI-SUCKER
K810416 · 3M Health Care, Sarns · Mar 1981