510(k) · Cleared
ClearedOtsuka Digital Feedback Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otsuka America Pharmaceutical, Inc. · OZW Ingestible Event Marker
Cleared on Jun 30, 2025 as substantially equivalent to K223463 (Otsuka America Pharmaceutical, Inc., 2023) after an 82-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Jun 30, 2025
- Review
- 82 days
- Class
- Class II
- Product code
- OZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963725 (1997). 19 ancestors in all, the oldest K854030 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations between
- 3 generations backK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- 2 generations backK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- 1 generation backK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
- This deviceK251088 Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 8 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 7 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 6 generations backK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- 5 generations backK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- 4 generations backK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- 3 generations backK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- 2 generations backK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- 1 generation backK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
- This deviceK251088 Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −8 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −7 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −6 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| −5 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| −4 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| −3 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| −2 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| −1 | K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023 | — |
| 0 (this device) | K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
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 OZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OZW device
- #1 K223463 Otsuka Digital Feedback Device-RWscore 10.9 · 8 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K223463 | Otsuka Digital Feedback Device-RWSummary page 5…tch Classification Name: Ingestible Event Marker, 21 CFR 880.6305 Product Code: OZW Predicate Device: Otsuka Digital Feedback Device-RW, K223463 Page 1 of 12… | 2023 |
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?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
How does its category compare?
All OZW devicesOZW Ingestible Event Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OZW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZW
Too few OZW 510(k)s in any year since 2007 to give a median.
Recalls per year · OZW
No recall names OZW since 2007.
Adverse event reports per year · OZW
2in 2018
MAUDE reports naming product code OZW, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Otsuka Digital Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device is intended to…
Read the full statement (121 words)
The Otsuka Digital Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device is intended to log, track, and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Otsuka Digital Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable and enables unattended data collection for clinical and research applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251088: Otsuka Digital Feedback Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251088
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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