# K033688: Micro H2 Breath Monitoring Device with Hydra Software Utility

- Pathway: 510(k) (Traditional)
- Applicant: Micro Direct, Inc.
- Decided: May 19, 2004 after 177 days
- Product code: NRH (System, Breath Measurement)
- Device class: 1
- Regulation: 21 CFR 862.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963376 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963376: Micro H2, Micro Direct, Inc. (1997) Summary page 1.
- (no number) HBT Sleuth: named in the summary without a submission number

## Indications for use
The Micro H 2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting. Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician. Target Population: Adult, Child and Infant.

Source page: https://510kreport.com/device/K033688
Methodology: https://510kreport.com/methodology