Cleared Traditional

K895014 - BAXTER BAFFLED TEE ADAPTER

K895014 is an FDA 510(k) clearance for BAXTER BAFFLED TEE ADAPTER, manufactured by Baxter Healthcare Corp. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K895014 · Baxter Healthcare Corp · Anesthesiology device
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Oct 1989
Decision
83d
Days
Class 1
Risk

K895014 is an FDA 510(k) clearance for the BAXTER BAFFLED TEE ADAPTER. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 83 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.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K895014

510(k) Number K895014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date October 30, 1989
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 57
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K895014.
CATHETER MOUNTS
K911421 · Intersurgical, Inc. · Jun 1991
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
K911425 · Intersurgical, Inc. · Jun 1991
AEROVENT
K894969 · Monaghan Medical Corp. · Oct 1989
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K895388 · Shiley, Inc. · Oct 1989
BODAI M.D.D. ADAPTOR(TM)
K881849 · B&B Medical Technologies, Inc. · Jul 1988
BODAI NEO2-SAFE(TM)
K873696 · B&B Medical Technologies, Inc. · Apr 1988