Cleared Traditional

K895479 - THAYER SEMI-RIGID CONDENSATE COLLECTION...

K895479 is an FDA 510(k) clearance for THAYER SEMI-RIGID CONDENSATE COLLECTION..., manufactured by Thayer Medical Corp.. The device is a Class 1 Anesthesiology device with product code BYH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K895479 · Thayer Medical Corp. · Anesthesiology device
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Mar 1990
Decision
179d
Days
Class 1
Risk

K895479 is an FDA 510(k) clearance for the THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thayer Medical Corp. devices

FDA 510(k) Submission Details - K895479

510(k) Number K895479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date March 09, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 140d · This submission: 179d
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 15
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K895479.
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
K921624 · Intertech Resources, Inc. · Jun 1992
VENT-TRAP CAT# WR1000
K900591 · Ventlab Corp. · Mar 1990
INTERTECH LARGE VOLUME WATER TRAP (LVW)
K882739 · Intertech Resources, Inc. · Aug 1988
SAFETY DRAIN
K881790 · Ballard Medical Products · Jun 1988
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR
K873447 · Dhd Medical Products Div. Diemolding Corp. · Oct 1987
AQUAVALVE
K864147 · Respiratory Care, Inc. · Dec 1986