Cleared Traditional

K853665 - SPLASH ADAPTOR

K853665 is an FDA 510(k) clearance for SPLASH ADAPTOR, manufactured by Ohio Medical Research, Inc.. The device is a Class 1 Anesthesiology device with product code BYH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K853665 · Ohio Medical Research, Inc. · Anesthesiology device
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Oct 1985
Decision
37d
Days
Class 1
Risk

K853665 is an FDA 510(k) clearance for the SPLASH ADAPTOR. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Ohio Medical Research, Inc. (Toledo, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 37 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.

FDA 510(k) Submission Details - K853665

510(k) Number K853665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date October 10, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 140d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

BYH Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K853665.
AQUAVALVE
K864147 · Respiratory Care, Inc. · Dec 1986
SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS
K860883 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
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
SHERWOOD WATER TRAP
K812569 · Sherwood Medical Co. · Sep 1981
K853665 · SPLASH ADAPTOR
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