510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864613Substantially Equivalent

502 Oxygen Saturation Monitor

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

K864613 is the FDA 510(k) clearance record for 502 OXYGEN SATURATION MONITOR, a class II device, cleared for Criticare Systems, Inc. on under FDA product code DQA (Oximeter). FDA records list 22 510(k) clearances for Criticare Systems, Inc., from to . As of , FDA records show no recalls naming K864613.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Criticare Systems, Inc. P.O. Box 26556, Milwaukee WI
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260