510(k) · Cleared
ClearedOtsuka Digital Feedback Device-RW
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 Aug 11, 2023 as substantially equivalent to K150494 (Proteus Digital Health, Inc., 2015) and 1 other predicate after a 268-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Aug 11, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- OZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K963725 (1997). 18 ancestors in all, the oldest K854030 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 6 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 5 generations backK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- 4 generations backK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- 3 generations backK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- 2 generations backK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- 1 generation backK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- This deviceK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251088 Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −6 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −5 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| −4 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| −3 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| −2 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| −1 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| 0 (this device) | K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K251088 Otsuka Digital Feedback Devicescore 12.0 · 9 generations · no Class I recall
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 |
|---|---|---|---|
| * | K150494 | Proteus Digital Health Feedback DeviceSummary page 4…earable patch Classification Name: Ingestible Event Marker, 21 CFR 880.6305 Product Code: OZW Predicate Device: Proteus Digital Health Feedback Device, K150494 Proteus Patch, Proteus Ingestible Sensor, K133263 K223463… | 2015 |
| * | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory)Summary page 4…6305 Product Code: OZW Predicate Device: Proteus Digital Health Feedback Device, K150494 Proteus Patch, Proteus Ingestible Sensor, K133263 K223463 1 General Device Descr… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251088 | Otsuka Digital Feedback Device | 2025 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K251088 (Otsuka America Pharmaceutical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150494.
How does its category compare?
All OZW devicesOZW Ingestible Event Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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-RW 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 the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW is…
Read the full statement (122 words)
The Otsuka Digital Feedback Device-RW 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 the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW 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-RW 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/K223463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223463: Otsuka Digital Feedback Device-RW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223463
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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