FDA product code NRH: System, Breath Measurement
NRH is the FDA product code for system, breath measurement. It is a Class I device, regulated under 21 CFR 862.1820 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under NRH, from 3 different applicants. The average 510(k) review took 130 days (median 164). FDA has posted 3 recalls for NRH devices, 3 initiated in the last five years.
Definition
Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.
Classification
| Field | Value |
|---|---|
| Device name | System, Breath Measurement |
| Device class | Class I |
| Regulation | 21 CFR 862.1820 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NRH clearance
Top NRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro Direct, Inc. | 2 | 2004-05-19 |
| Enteron, Inc. | 1 | 1988-06-28 |
| Vitalograph , Ltd. | 1 | 1988-06-02 |
Most recent NRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033688 | Micro Direct, Inc. | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | 2004-05-19 | 177 |
| K963376 | Micro Direct, Inc. | MICRO H2 | 1997-01-24 | 150 |
| K882499 | Enteron, Inc. | JAYCO HYDROGEN MONITOR | 1988-06-28 | 11 |
| K874892 | Vitalograph , Ltd. | VITALOGRAPH-EC60 HYDROGEN MONITOR | 1988-06-02 | 184 |
Recalls for NRH devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code NRH?
NRH is the FDA product code for system, breath measurement. It is a Class I device, regulated under 21 CFR 862.1820 and reviewed by the Clinical Chemistry panel.
What device class is NRH?
Class I, regulation 21 CFR 862.1820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NRH?
Across 4 cleared submissions the average was 130 days from receipt to decision (median 164).
Which companies have the most NRH clearances?
Micro Direct, Inc. (2); Enteron, Inc. (1); Vitalograph , Ltd. (1).
Have NRH devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NRH
- Run a recall and safety report across every NRH manufacturer
- Watch product code NRH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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