510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890817Substantially Equivalent

Omni-Trak (Patient Monitor)

Invivo Research, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890817 is the FDA 510(k) clearance record for OMNI-TRAK (PATIENT MONITOR), a class II device, cleared for Invivo Research, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 14 510(k) clearances for Invivo Research, Inc., from to . As of , FDA records show no recalls naming K890817.

Clearance record

Decision date
Received
(174 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Invivo Research, Inc. 11800 Research Pkwy., Orlando FL
Third party review
No

Clearances, product code CCK

Trailing 12 months
3 clearances under product code CCK in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260