# K963376: Micro H2

- Pathway: 510(k) (Traditional)
- Applicant: Micro Direct, Inc.
- Decided: Jan 24, 1997 after 150 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033688: Micro H2 Breath Monitoring Device with Hydra Software Utility (2004), 0 descendants of its own

## Indications for use
The Micro H2 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/K963376
Methodology: https://510kreport.com/methodology