Cleared Traditional

K873696 - BODAI NEO2-SAFE(TM)

K873696 is an FDA 510(k) clearance for BODAI NEO2-SAFE(TM), manufactured by B&B Medical Technologies, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 213-day FDA review.

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

FDA 510(k) Submission Details - K873696

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
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 46
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K873696.
BAXTER BAFFLED TEE ADAPTER
K895014 · Baxter Healthcare 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
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