510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894100Substantially Equivalent

Oxytrak(tm) Pulse Oximeter

Critikon Company, LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894100 is the FDA 510(k) clearance record for OXYTRAK(TM) PULSE OXIMETER, a class II device, cleared for Critikon Company, LLC on under FDA product code DQA (Oximeter). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K894100.

Clearance record

Decision date
Received
(334 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Critikon Company, LLC 4110 George Rd., Tampa FL
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