Cleared Traditional

K921742 - OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY

K921742 is an FDA 510(k) clearance for OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K921742 · Ohmeda Medical · Anesthesiology device
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May 1993
Decision
408d
Days
Class 2
Risk

K921742 is an FDA 510(k) clearance for the OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K921742

510(k) Number K921742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date May 26, 1993
Days to Decision 408 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 140d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSZ Gas-machine, Anesthesia

All 188
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K921742.
NARKOMED 2C ANESTHESIA SYSTEM
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K913791 · Ohmeda Anesthesia Systems Therapy Group · Apr 1993
SENSOR GUI
K923519 · Hospitronic · Dec 1992
FTS-200 GAS SYSTEM
K920944 · Trek Medical Products, Inc. · May 1992
K921742 · OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
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