FDA product code OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity
OBH is the FDA product code for monitor, extracellular fluid, lymphedema, extremity. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under OBH, 3 in the last five years, from 3 different applicants. The average 510(k) review took 242 days (median 115); 121 days on average over the last three years. FDA has posted 1 recall for OBH devices, 1 initiated in the last five years.
Definition
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 1 | 90 |
| 2022 | 1 | 88 |
| 2023 | 1 | 66 |
| 2026 | 1 | 121 |
Compare with all 510(k) review times · Search every OBH clearance
Top OBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ImpediMed Limited | 6 | 2026-01-28 |
| Delfin Technologies, Ltd. | 2 | 2022-05-27 |
| Impedimed Pty , Ltd. | 2 | 2008-10-03 |
Most recent OBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253224 | ImpediMed Limited | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | 2026-01-28 | 121 |
| K230530 | ImpediMed Limited | SOZO Pro | 2023-05-04 | 66 |
| K220557 | Delfin Technologies, Ltd. | MoistureMeterD Compact, LymphScanner | 2022-05-27 | 88 |
| K180126 | ImpediMed Limited | SOZO | 2018-04-16 | 90 |
| K172122 | ImpediMed Limited | SOZO | 2017-08-11 | 29 |
Recalls for OBH devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-17.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code OBH?
OBH is the FDA product code for monitor, extracellular fluid, lymphedema, extremity. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel.
What device class is OBH?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBH?
Across 10 cleared submissions the average was 242 days from receipt to decision (median 115).
Which companies have the most OBH clearances?
ImpediMed Limited (6); Delfin Technologies, Ltd. (2); Impedimed Pty , Ltd. (2).
Have OBH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-08-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OBH
- Run a recall and safety report across every OBH manufacturer
- Watch product code OBH 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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