510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083617Substantially Equivalent

Apieron Insight Eno System

Apieron, Inc., Menlo Park CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083617 is the FDA 510(k) clearance record for APIERON INSIGHT ENO SYSTEM, a class II device, cleared for Apieron, Inc. on under FDA product code MXA (System, Test, Breath Nitric Oxide). FDA records list 2 510(k) clearances for Apieron, Inc., from to . As of , FDA records show no recalls naming K083617.

Clearance record

Decision date
Received
(50 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
Apieron, Inc. 155 Jefferson Dr., Menlo Park 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