Cleared Traditional

SARNS MINI-SUCKER (K810416) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K810416 · 3M Health Care, Sarns · General & Plastic Surgery device
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Mar 1981
Decision
15d
Days
Class 1
Risk

K810416 is an FDA 510(k) clearance for the SARNS MINI-SUCKER. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 15 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K810416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 05, 1981
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 12
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K810416.
BBL STREP GROUPING KIT
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ARGYLE VAC-U-CARE 100CC SUCTION RESERV
K821563 · Sherwood Medical Co. · Jun 1982
DEPUY HEMODRAIN
K811557 · Depuy, Inc. · Jul 1981
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
CLOSED WOUND VACUUM DRAINAGE SYSTEM
K790654 · 3M Company · Apr 1979