Cleared Traditional

K801221 - THORA-DRAIN III PLASTIC DRAINAGE SYSTEM

K801221 is the FDA 510(k) clearance for THORA-DRAIN III PLASTIC DRAINAGE SYSTEM by Chesebrough-Pond'S U.S.A. Co.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K801221 · Chesebrough-Pond'S U.S.A. Co. · General Hospital
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Jun 1980
Decision
18d
Days
Class 2
Risk

K801221 is an FDA 510(k) clearance for the THORA-DRAIN III PLASTIC DRAINAGE SYSTEM. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 18 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K801221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1980
Decision Date June 09, 1980
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 10
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K801221.
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
SEP-T-VAC SUCTION CANNISTER W/ TUBING
K790379 · Sherwood Medical Co. · Apr 1979
SUCTION CANISTER
K781279 · Abco Dealers, Inc. · Aug 1978