Cleared Traditional

K802174 - ARGYLE SUCTION CANISTER W/DISP. LINER

K802174 is the FDA 510(k) clearance for ARGYLE SUCTION CANISTER W/DISP. LINER by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802174 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
17d
Days
Class 2
Risk

K802174 is an FDA 510(k) clearance for the ARGYLE SUCTION CANISTER W/DISP. LINER. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 17 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K802174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1980
Decision Date September 26, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
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 29
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K802174.
PLEURAL DRAINAGE SYSTEM #PDS-4300
K812224 · Bentley Laboratories, Inc. · Sep 1981
VAC-RITE SUNCTION COLLECTION
K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ELECTRO-SUCTION UNIT
K810892 · Jedmed Instrument Co. · Apr 1981
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