Cleared Traditional

K924341 - HAYEK OSCILLATOR(TM)

K924341 is an FDA 510(k) clearance for HAYEK OSCILLATOR(TM), manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K924341 · Respironics, Inc. · Anesthesiology device
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Jul 1993
Decision
328d
Days
Class 2
Risk

K924341 is an FDA 510(k) clearance for the HAYEK OSCILLATOR(TM). Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5935 - 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. Elevated predicate reliance profile. 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K924341

510(k) Number K924341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date July 21, 1993
Days to Decision 328 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 140d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYT Device Classification - Class 2, Special Controls

Product Code BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5935
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 - BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)

All 7
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K924341.
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · Puritan Bennett Corp. · Mar 1991
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · J. H. Emerson Co. · Nov 1990
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · J. H. Emerson Co. · Aug 1988
Q101 DIAGNOSTIC SPIROMETER
K863300 · Quinton, Inc. · Nov 1986
PTR MK II VENTILATOR
K860692 · Bear Medical Systems, Inc. · May 1986