510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033688Substantially Equivalent

Micro H2 Breath Monitoring Device with Hydra Software Utility

Micro Direct, Inc., Lewiston ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033688 is the FDA 510(k) clearance record for MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY, a class I device, cleared for Micro Direct, Inc. on under FDA product code NRH (System, Breath Measurement). FDA's definition for product code NRH reads: "Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions". FDA records list 9 510(k) clearances for Micro Direct, Inc., from to . As of , FDA records show no recalls naming K033688.

Clearance record

Decision date
Received
(177 days to decision)
Product code
NRH System, Breath Measurement
Regulation
21 CFR 862.1820
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Micro Direct, Inc. 803 Webster St., Lewiston ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRH

Trailing 12 months

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

FDA records show no clearances under product code NRH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRH, 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