510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093525Substantially Equivalent

Ace/statcheck II CO2 Indicator, Ace/statcheck II CO2 Indicator Arm Assemby Adult Statcheck Resuscitator with Ace/statche

Salter Labs, Mocksville NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K093525 is the FDA 510(k) clearance record for ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE, a class II device, cleared for Ventlab Corp. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 74 510(k) clearances for Salter Labs, from to . As of , FDA records show one recall naming K093525.

Clearance record

Decision date
Received
(24 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
Ventlab Corp. 155 Boyce Dr., Mocksville NC
510(k) summary
Statement
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