Cleared Traditional

K771737 - SUCTION CANISTER

K771737 is an FDA 510(k) clearance for SUCTION CANISTER, manufactured by Bemis Health Care. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

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

FDA 510(k) Submission Details - K771737

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.

GCX Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K771737.
OHIO THORACIC COLLECTION UNIT
K801942 · Ohio Medical Products · Sep 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · Sherwood Medical Co. · Sep 1980
TUBING, DYNACOR UNIVERSAL
K790055 · Medline Industries, Inc. · Feb 1979
HEPARINIZED WOUND SUCTION TUBING
K760812 · Sherwood Medical Industries · Nov 1976
HEPARINIZED SARATOGA SUMP DRAIN
K760813 · Sherwood Medical Industries · Nov 1976
HEPARINIZED PENROSE TUBING
K760814 · Sherwood Medical Industries · Nov 1976