510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110810Substantially Equivalent

Anascient Breath Monitor

Invoy Technologies, LLC, Chandler AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K110810 is the FDA 510(k) clearance record for ANASCIENT BREATH MONITOR, a class II device, cleared for Invoy Technologies, LLC on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list one 510(k) clearance for Invoy Technologies, LLC. As of , FDA records show no recalls naming K110810.

Clearance record

Decision date
Received
(90 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Invoy Technologies, LLC 1820 E.Ray Rd., Chandler AZ
510(k) summary
Statement
Third party review
Yes

Clearances, product code BZL

Trailing 12 months

FDA records hold no clearances under product code BZL in the trailing twelve months.

FDA records show no clearances under product code BZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260