510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903745Substantially Equivalent

The Hayek Oscillator

Flexco Medical Instruments, Zurich, Switzerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903745 is the FDA 510(k) clearance record for THE HAYEK OSCILLATOR, a class II device, cleared for Flexco Medical Instruments on under FDA product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)). FDA records list one 510(k) clearance for Flexco Medical Instruments. As of , FDA records show no recalls naming K903745.

Clearance record

Decision date
Received
(85 days to decision)
Product code
BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Regulation
21 CFR 868.5935
Device class
Class II
Review panel
Anesthesiology
Applicant
Flexco Medical Instruments Kirchweg 151, 8102, Zurich, Switzerland, CH
Third party review
No

Clearances, product code BYT

Trailing 12 months

FDA records hold no clearances under product code BYT in the trailing twelve months.

FDA records show no clearances under product code BYT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260