De Novo · Granted
GrantedProteus Ingestion Confinmation Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proteus Biomedical, Inc. · OZW Ingestible Event Marker
Granted on Jul 10, 2012 as a new device type through De Novo after a 60-day review. 7 later devices descend from it.
- Decided
- Jul 10, 2012
- Review
- 60 days
- Class
- Class II
- Product code
- OZW
- Recalls
- None
7 later devices descend from it, 1 citing it directly.
- This deviceDEN120011 Proteus Ingestion Confinmation SystemsProteus Biomedical, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK251088 Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013 · cites it directly6descendants
- K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014 · 2 generations on4descendants
- K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015 · 3 generations on3descendants
- K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023 · 3 generations on1descendant
- K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120011 | Proteus Ingestion Confinmation Systems | Proteus Biomedical, Inc. | 2012 | — |
| +1 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| +2 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| +3 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| +3 | K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023 | — |
| +4 | K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131009 | Proteus Patch, Ingestible Sensor (Accessory) | 2013 | 6 |
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?
- Of its descendants, K131009 (Proteus Digital Health, Inc., 2013) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OZW devicesOZW Ingestible Event Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 | — |
https://510kreport.com/device/DEN120011 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN120011: Proteus Ingestion Confinmation Systems.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN120011
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026