Cleared Traditional

K873974 - TILSON TRACH GUARD

K873974 is an FDA 510(k) clearance for TILSON TRACH GUARD, manufactured by Beevers Mfg. & Supply, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K873974 · Beevers Mfg. & Supply, Inc. · Anesthesiology device
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Dec 1987
Decision
84d
Days
Class 1
Risk

K873974 is an FDA 510(k) clearance for the TILSON TRACH GUARD. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Beevers Mfg. & Supply, Inc. (Boise, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 - K873974

510(k) Number K873974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1987
Decision Date December 22, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 73
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K873974.
BODAI NEO2-SAFE(TM)
K873696 · B&B Medical Technologies, Inc. · Apr 1988
FLEX TUBE
K881230 · Intertech Resources, Inc. · Apr 1988
MEDICOMP STRAIGHT SWIVEL ADAPTOR
K880434 · Medicomp, Inc. · Mar 1988
MEDICOMP INHALANT MASK ELBOW
K864896 · Medicomp, Inc. · Feb 1987
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K865046 · Salter Labs · Jan 1987
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
K860838 · Inspiron Corp. · Apr 1986
K873974 · TILSON TRACH GUARD
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