510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K213611Substantially Equivalent

Fenom Pro

Caire Diagnostics, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213611 is the FDA 510(k) clearance record for Fenom Pro, a class II device, cleared for Caire Diagnostics, Inc. on under FDA product code MXA (System, Test, Breath Nitric Oxide). FDA records list one 510(k) clearance for Caire Diagnostics, Inc. As of , FDA records show no recalls naming K213611.

Clearance record

Decision date
Received
(569 days to decision)
Product code
MXA System, Test, Breath Nitric Oxide
Regulation
21 CFR 862.3080
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Caire Diagnostics, Inc. 7020 Koll Center Pkwy. Suite 110, Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXA

Trailing 12 months
1 clearance under product code MXA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260