510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K942230Substantially Equivalent

Oxycon-Alpha

Mijnhardt B.V., 3981 Ae Bunnik, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942230 is the FDA 510(k) clearance record for OXYCON-ALPHA, a class II device, cleared for Mijnhardt B.V. on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list one 510(k) clearance for Mijnhardt B.V. As of , FDA records show no recalls naming K942230.

Clearance record

Decision date
Received
(318 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Mijnhardt B.V. Schoudermantel 37, 3981 Ae Bunnik, NL
510(k) summary
Statement
Third party review
No

Clearances, product code BTY

Trailing 12 months
1 clearance under product code BTY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260