Cleared Traditional

K810574 - SUCTION COLLECTION BOTTLE

K810574 is the FDA 510(k) clearance for SUCTION COLLECTION BOTTLE by Harvard Laboratories. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K810574 · Harvard Laboratories · General Hospital
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Apr 1981
Decision
49d
Days
Class 2
Risk

K810574 is an FDA 510(k) clearance for the SUCTION COLLECTION BOTTLE, DISPOSABLE. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Harvard Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 21, 1981 after a review of 49 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 Harvard Laboratories devices

Submission Details

510(k) Number K810574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date April 21, 1981
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 16
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K810574.
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
CONPHAR SILICONE DRAINS-STERILE
K791254 · Conphar, Inc. · Aug 1979