Cleared Traditional

SUCTION CANISTER (K771737) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771737 · Bemis Health Care · General Hospital
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Dec 1977
Decision
96d
Days
Class 2
Risk

K771737 is an FDA 510(k) clearance for the SUCTION CANISTER. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Bemis Health Care (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bemis Health Care devices

Submission Details

510(k) Number K771737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date December 20, 1977
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 13
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K771737.
ARGYLE COMPACT CHEST DRAINAGE SYS.
K802440 · Sherwood Medical Co. · Oct 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · Sherwood Medical Co. · Sep 1980
TUBING, DYNACOR UNIVERSAL
K790055 · Medline Industries, Inc. · Feb 1979
SUCTION INSTRUMENT, MACBICK POOLE TIP
K760216 · C.R. Bard, Inc. · Aug 1976
SUCTION INSTRUMENT, MACBICK DIS. FRAZ.
K760217 · C.R. Bard, Inc. · Aug 1976