510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K902113Substantially Equivalent

Vitalograph - Breathco Monitor

Mcneill Intl., Inc., Willoughby OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902113 is the FDA 510(k) clearance record for VITALOGRAPH - BREATHCO MONITOR, a class II device, cleared for Mcneill Intl., Inc. on under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). FDA records list one 510(k) clearance for Mcneill Intl., Inc. As of , FDA records show no recalls naming K902113.

Clearance record

Decision date
Received
(168 days to decision)
Product code
CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Regulation
21 CFR 868.1430
Device class
Class II
Review panel
Anesthesiology
Applicant
Mcneill Intl., Inc. 2904 Bishop Rd., Willoughby OH
Third party review
No

Clearances, product code CCJ

Trailing 12 months
1 clearance under product code CCJ 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 CCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260