510(k) · Cleared
ClearedMicro H2 Breath Monitoring Device with Hydra Software Utility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Direct, Inc. · NRH System, Breath Measurement
Cleared on May 19, 2004 as substantially equivalent to K963376 (Micro Direct, Inc., 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 19, 2004
- Review
- 177 days
- Class
- Class I
- Product code
- NRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963376 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963376 Micro H2Micro Direct, Inc. · 1997
- This deviceK033688 Micro H2 Breath Monitoring Device with Hydra Software UtilityMicro Direct, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963376 | Micro H2 | Micro Direct, Inc. | 1997 | — |
| 0 (this device) | K033688 | Micro H2 Breath Monitoring Device with Hydra Software Utility | Micro Direct, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963376 | Micro H2Summary page 1…Xylose Test System Regulation Number: 21 CFR 862.1820 Predicate Devices, 510(k) Numbers: Micro H 2, K963376 HBT Sleuth, N/A Indications For Use: The Micro H 2 is a hand held hydr… | 1997 |
| * | — | HBT Sleuth Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NRH devicesNRH System, Breath Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRH
FDA has decided no NRH device since 2007.
Median 510(k) review, days · NRH
Too few NRH 510(k)s in any year since 2007 to give a median.
Recalls per year · NRH
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRH
No MAUDE report names NRH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033688: Micro H2 Breath Monitoring Device with Hydra Software Utility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033688
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026