Cleared Traditional

K811203 - SAF SINGLE-USE AEROSOL FILTER

K811203 is an FDA 510(k) clearance for SAF SINGLE-USE AEROSOL FILTER, manufactured by Sorensen Research. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K811203 · Sorensen Research · General & Plastic Surgery device
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May 1981
Decision
20d
Days
Class 1
Risk

K811203 is an FDA 510(k) clearance for the SAF SINGLE-USE AEROSOL FILTER. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 20 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 Sorensen Research devices

FDA 510(k) Submission Details - K811203

510(k) Number K811203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date May 21, 1981
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 51
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K811203.
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
DEPUY HEMODRAIN
K811557 · Depuy, Inc. · Jul 1981
SARNS MINI-SUCKER
K810416 · 3M Health Care, Sarns · Mar 1981
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · Edward Weck, Inc. · Aug 1980
P-S SURGICAL DRAIN
K801442 · Pudenz-Schulte Medical Research Corp. · Jul 1980