Cleared Traditional

K921726 - HAYEK OSCILLATOR

K921726 is an FDA 510(k) clearance for HAYEK OSCILLATOR, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K921726 · Respironics, Inc. · Anesthesiology device
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Apr 1992
Decision
15d
Days
Class 2
Risk

K921726 is an FDA 510(k) clearance for the HAYEK OSCILLATOR, MODIFICATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on April 23, 1992 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K921726

510(k) Number K921726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date April 23, 1992
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K921726.
MODEL 6213 REMOTE ALARM
K914424 · Aequitron Medical, Inc. · Sep 1992
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · Puritan Bennett Corp. · Jul 1992
BEAR 7 VENTILATOR
K912619 · Bear Medical Systems, Inc. · Jun 1992
BIRD NEBULIZATION SYNCHRONIZER
K911336 · Bird Products Corp. · Nov 1991
VENTILATOR STAND
K914485 · Bird Products Corp. · Oct 1991
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991