Cleared Traditional

BODAI NEO2-SAFE(TM) (K873696) - FDA 510(k) Clearance

Class I Anesthesiology device.

K873696 · B&B Medical Technologies, Inc. · Anesthesiology device
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Apr 1988
Decision
213d
Days
Class 1
Risk

K873696 is an FDA 510(k) clearance for the BODAI NEO2-SAFE(TM). Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 213 days - an extended review 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: 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 B&B Medical Technologies, Inc. devices

Submission Details

510(k) Number K873696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date April 14, 1988
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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)

Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K873696.
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
BAXTER BAFFLED TEE ADAPTER
K895014 · Baxter Healthcare Corp · Oct 1989
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K895388 · Shiley, Inc. · Oct 1989
ARGYLE 15MM SWIVEL CONNECTOR
K850625 · Sherwood Medical Co. · Mar 1985
OHMEDA DOUBLE SWIVEL ADAPTER
K844656 · Ohmeda Medical · Feb 1985
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K812000 · Mallinckrodt Critical Care · Aug 1981