FDA product code OZW: Ingestible Event Marker
OZW is the FDA product code for ingestible event marker. It is a Class II device, regulated under 21 CFR 880.6305 and reviewed by the Cardiovascular panel. FDA has cleared 7 510(k) submissions under OZW, 2 in the last five years, from 3 different applicants. The average 510(k) review took 147 days (median 107); 82 days on average over the last three years. 1 De Novo request was granted under it.
Definition
To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device
Classification
| Field | Value |
|---|---|
| Device name | Ingestible Event Marker |
| Device class | Class II |
| Regulation | 21 CFR 880.6305 |
| Review panel | CV — Cardiovascular |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for OZW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 399 |
| 2023 | 1 | 268 |
| 2025 | 1 | 82 |
Compare with all 510(k) review times · Search every OZW clearance
Top OZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Proteus Digital Health, Inc. | 4 | 2015-06-27 |
| Otsuka America Pharmaceutical, Inc. | 2 | 2025-06-30 |
| Etectrx, Inc. | 1 | 2019-12-06 |
Most recent OZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251088 | Otsuka America Pharmaceutical, Inc. | Otsuka Digital Feedback Device | 2025-06-30 | 82 |
| K223463 | Otsuka America Pharmaceutical, Inc. | Otsuka Digital Feedback Device-RW | 2023-08-11 | 268 |
| K183052 | Etectrx, Inc. | ID-Cap System | 2019-12-06 | 399 |
| K150494 | Proteus Digital Health, Inc. | Proteus Digital Health Feedback Device | 2015-06-27 | 122 |
| K133263 | Proteus Digital Health, Inc. | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | 2014-02-07 | 107 |
Recalls for OZW devices
openFDA lists no recalls for product code OZW.
Frequently asked questions
What is FDA product code OZW?
OZW is the FDA product code for ingestible event marker. It is a Class II device, regulated under 21 CFR 880.6305 and reviewed by the Cardiovascular panel.
What device class is OZW?
Class II, regulation 21 CFR 880.6305. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZW?
Across 7 cleared submissions the average was 147 days from receipt to decision (median 107).
Which companies have the most OZW clearances?
Proteus Digital Health, Inc. (4); Otsuka America Pharmaceutical, Inc. (2); Etectrx, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OZW
- Run a recall and safety report across every OZW manufacturer
- Watch product code OZW 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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