Cleared Traditional

K802891 - ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT

K802891 is an FDA 510(k) clearance for ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT, manufactured by Sherwood Medical Co.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802891 · Sherwood Medical Co. · Anesthesiology device
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Dec 1980
Decision
32d
Days
Class 2
Risk

K802891 is an FDA 510(k) clearance for the ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - the FDA anesthesiology and respiratory 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K802891

510(k) Number K802891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 19, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 18
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K802891.
CO TEST
K843845 · Erich Jaeger, Inc. · Oct 1984
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · Instrumentarium Corp. · Dec 1983
ECOLYZER #200/COHB ANALYZER SYS
K832655 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
DIFFUSION OPTION, OMNI-LAB
K781871 · Ohio Medical Products · Jan 1979
DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
K760169 · Hewlett-Packard Co. · Jul 1976