Cleared Traditional

K812224 - PLEURAL DRAINAGE SYSTEM #PDS-4300

K812224 is the FDA 510(k) clearance for PLEURAL DRAINAGE SYSTEM #PDS-4300 by Bentley Laboratories, Inc.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K812224 · Bentley Laboratories, Inc. · General Hospital
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Sep 1981
Decision
30d
Days
Class 2
Risk

K812224 is an FDA 510(k) clearance for the PLEURAL DRAINAGE SYSTEM #PDS-4300. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 30 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K812224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1981
Decision Date September 09, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K812224.
COMPACT 2000
K851892 · Atrium Medical Corp. · Jun 1985
ABCO SUCTION CANISTER
K851316 · Abco Dealers, Inc. · May 1985
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · C.R. Bard, Inc. · Mar 1983
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