De Novo · Granted
GrantedGiven Pillcam Colon 2 Capsule Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging, Ltd. · PGD Colon Capsule Imaging System
Granted on Jan 29, 2014 as a new device type through De Novo after a 426-day review. 7 later devices descend from it.
- Decided
- Jan 29, 2014
- Review
- 426 days
- Class
- Class II
- Product code
- PGD
- Recalls
- None
7 later devices descend from it, 2 citing it directly.
- This deviceDEN120023 Given Pillcam Colon 2 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK153466 PillCam COLON 2 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- Descendant · 4 generations on · 1 of its ownK230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023
- Descendant · 4 generations on · 0 of its ownK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153466PillCam COLON 2 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2016 · cites it directly5descendants
- K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017 · 2 generations on4descendants
- K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021 · 3 generations on3descendants
- K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023 · 4 generations on1descendant
- K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120023 | Given Pillcam Colon 2 Capsule Endoscopy System | Given Imaging, Ltd. | 2014 | — |
| +1 | K153466 | PillCam COLON 2 Capsule Endoscopy System | Given Imaging, Ltd. | 2016 | — |
| +2 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
| +3 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| +4 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023 | — |
| +4 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 PGD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K153466 (Given Imaging, Ltd., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PGD devicesPGD Colon Capsule Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGD
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PGD
Too few PGD 510(k)s in any year since 2007 to give a median.
Recalls per year · PGD
No recall names PGD since 2007.
Adverse event reports per year · PGD
1in 2025
MAUDE reports naming product code PGD, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN120023 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN120023: Given Pillcam Colon 2 Capsule Endoscopy System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN120023
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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