510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853331Substantially Equivalent

Osm-1 Oxygen Saturation Monitor

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

K853331 is the FDA 510(k) clearance record for OSM-1 OXYGEN SATURATION MONITOR, a class II device, cleared for Criticare Systems, Inc. on under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic). FDA records list 22 510(k) clearances for Criticare Systems, Inc., from to . As of , FDA records show no recalls naming K853331.

Clearance record

Decision date
Received
(159 days to decision)
Product code
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation
21 CFR 870.2780
Device class
Class II
Review panel
Cardiovascular
Applicant
Criticare Systems, Inc. P.O. Box 26556, Milwaukee WI
Third party review
No

Clearances, product code JOM

Trailing 12 months

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

FDA records show no clearances under product code JOM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOM, 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