Cleared Traditional

K822902 - MINI-VAC DRAIN SYSTEM

K822902 is an FDA 510(k) clearance for MINI-VAC DRAIN SYSTEM, manufactured by Angus Medical Co.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K822902 · Angus Medical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
90d
Days
Class 1
Risk

K822902 is an FDA 510(k) clearance for the MINI-VAC DRAIN SYSTEM. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Angus Medical Co. (Walker, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Angus Medical Co. devices

FDA 510(k) Submission Details - K822902

510(k) Number K822902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1982
Decision Date December 28, 1982
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

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 52
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K822902.
BBL STREP GROUPING KIT
K830510 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1983
SUCTION RESERVOIR
K830607 · Sil-Med Corp. · May 1983
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
PS-ROUND SURG. DRAIN & CONNECTOR
K813377 · Pudenz-Schulte Medical Research Corp. · Jan 1982