Cleared Traditional

K903745 - THE HAYEK OSCILLATOR

K903745 is an FDA 510(k) clearance for THE HAYEK OSCILLATOR, manufactured by Flexco Medical Instruments. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K903745 · Flexco Medical Instruments · Anesthesiology device
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Nov 1990
Decision
85d
Days
Class 2
Risk

K903745 is an FDA 510(k) clearance for the THE HAYEK OSCILLATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Flexco Medical Instruments (Zurich, Switzerland, CH). The FDA issued a Cleared decision on November 9, 1990 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K903745

510(k) Number K903745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date November 09, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 16
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K903745.
NEV-10 NEGATIVE PRESSURE VENTILATOR
K910947 · Lifecare Services, Inc. · Jun 1991
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
EASY BREATHER MODEL 100 ACCESSORIES
K902300 · Progressive Productions , Ltd. · Jul 1990
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
EMERSON 33-CR CHEST RESPIRATOR
K894649 · Emerson Intl. Co. · Oct 1989
K903745 · THE HAYEK OSCILLATOR
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