510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921309Substantially Equivalent

Model 508 Patient Monitor

Criticare Systems, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921309 is the FDA 510(k) clearance record for MODEL 508 PATIENT MONITOR, a class II device, cleared for Criticare Systems, Inc. on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 22 510(k) clearances for Criticare Systems, Inc., from to . As of , FDA records show no recalls naming K921309.

Clearance record

Decision date
Received
(647 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Criticare Systems, Inc. P.O. Box 26556, Milwaukee WI
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