Cleared Traditional

K812139 - VACUUM SUCTION FILTER

K812139 is an FDA 510(k) clearance for VACUUM SUCTION FILTER, manufactured by K & G Healthcare Ind., Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812139 · K & G Healthcare Ind., Inc. · General Hospital
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Aug 1981
Decision
23d
Days
Class 2
Risk

K812139 is an FDA 510(k) clearance for the VACUUM SUCTION FILTER. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by K & G Healthcare Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 23 days - a notably fast clearance cycle.

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: 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 K & G Healthcare Ind., Inc. devices

FDA 510(k) Submission Details - K812139

510(k) Number K812139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date August 20, 1981
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDQ Device Classification - Class 2, Special Controls

Product Code KDQ Bottle, Collection, Vacuum
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 - KDQ Bottle, Collection, Vacuum

All 35
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K812139.
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · C.R. Bard, Inc. · Mar 1983
THORACIC DRAINAGE SET #55-DB2-G
K812746 · J. H. Emerson Co. · Oct 1981
PLEURAL DRAINAGE SYSTEM #PDS-4300
K812224 · Bentley Laboratories, Inc. · Sep 1981
VAC-RITE SUNCTION COLLECTION
K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ELECTRO-SUCTION UNIT
K810892 · Jedmed Instrument Co. · Apr 1981
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · Sherwood Medical Co. · Sep 1980