510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993641Substantially Equivalent

Metalyzer, Model 2; Metalyzer, Model 3

Cortex Biophysik GmbH, Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993641 is the FDA 510(k) clearance record for METALYZER, MODEL 2; METALYZER, MODEL 3, a class II device, cleared for Cortex Biophysik GmbH on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 2 510(k) clearances for Cortex Biophysik GmbH, from to . As of , FDA records show no recalls naming K993641.

Clearance record

Decision date
Received
(413 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Cortex Biophysik GmbH 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary
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