Cleared Traditional

K812569 - SHERWOOD WATER TRAP

K812569 is the FDA 510(k) clearance for SHERWOOD WATER TRAP by Sherwood Medical Co.. It is a Class 1 Anesthesiology device (product code BYH) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K812569 · Sherwood Medical Co. · Anesthesiology device
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Sep 1981
Decision
16d
Days
Class 1
Risk

K812569 is an FDA 510(k) clearance for the SHERWOOD WATER TRAP. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5995 - 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

Submission Details

510(k) Number K812569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1981
Decision Date September 25, 1981
Days to Decision 16 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
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYH Drain, Tee (water Trap)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5995
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYH Drain, Tee (water Trap)

All 7
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K812569.
SELF-SEALING WATER TRAP/ACCESSORIES
K860884 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
AQUA TRAP
K834573 · Airlife, Inc. · Mar 1984
MOISTURE TRAP
K820936 · Dhd Medical Products Div. Diemolding Corp. · Apr 1982
TRACH MIST UNIT W/OR WITHOUT ELBOW
K800990 · Airlife, Inc. · May 1980
MOISTURE TRAP
K792390 · Dhd Medical Products Div. Diemolding Corp. · Dec 1979