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
DEN030001Unknown

Niox Article No: 02-1000

Aerocrine AB, San Diego CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN030001 is the FDA 510(k) clearance record for NIOX ARTICLE NO: 02-1000, a class II device, cleared for Aerocrine AB on under FDA product code MXA (System, Test, Breath Nitric Oxide). FDA records list 6 510(k) clearances for Aerocrine AB, from to . As of , FDA records show no recalls naming DEN030001.

Clearance record

Decision date
Received
(43 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
Aerocrine AB 16787 Bernardo Center Dr.,, San Diego CA
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