Cleared Traditional

CALIBRATED BREATHING SYSTEM COLLECTION (K811955) - FDA 510(k) Clearance

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

K811955 · Anchor Brush Co., Inc. · General Hospital
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Aug 1981
Decision
34d
Days
Class 2
Risk

K811955 is an FDA 510(k) clearance for the CALIBRATED BREATHING SYSTEM COLLECTION. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Anchor Brush Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1981 after a review of 34 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 Anchor Brush Co., Inc. devices

Submission Details

510(k) Number K811955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date August 04, 1981
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 9
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K811955.
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
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ABCO SUCTION CANISTER
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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
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · Sherwood Medical Co. · Sep 1980
CONPHAR SILICONE DRAINS-STERILE
K791254 · Conphar, Inc. · Aug 1979