Cleared Traditional

K800861 - SNYDER HEMOVAC CHEST DRAINAGE SOLUTION

K800861 is an FDA 510(k) clearance for SNYDER HEMOVAC CHEST DRAINAGE SOLUTION, manufactured by Snyder Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K800861 · Snyder Laboratories, Inc. · General Hospital
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May 1980
Decision
16d
Days
Class 2
Risk

K800861 is an FDA 510(k) clearance for the SNYDER HEMOVAC CHEST DRAINAGE SOLUTION. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Snyder Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 16 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 Snyder Laboratories, Inc. devices

FDA 510(k) Submission Details - K800861

510(k) Number K800861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1980
Decision Date May 02, 1980
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 37
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K800861.
ELECTRO-SUCTION UNIT
K810892 · Jedmed Instrument Co. · Apr 1981
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · Sherwood Medical Co. · Sep 1980
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
K801221 · Chesebrough-Pond'S U.S.A. Co. · Jun 1980
CONPHAR SILICONE DRAINS-STERILE
K791254 · Conphar, Inc. · Aug 1979
SEP-T-VAC SUCTION CANNISTER W/ TUBING
K790379 · Sherwood Medical Co. · Apr 1979
SUCTION CANISTER
K781279 · Abco Dealers, Inc. · Aug 1978