Cleared Traditional

K812569 - SHERWOOD WATER TRAP (FDA 510(k) Clearance)

Class I Anesthesiology device.

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
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 139d · 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.