510(k) · Cleared
ClearedPillCam 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
Cleared on Jan 14, 2016 as substantially equivalent to DEN120023 (Given Imaging, Ltd., 2014) after a 44-day review. Its family tree reaches back 1 generation to 2014. 5 later devices descend from it.
- Decided
- Jan 14, 2016
- Review
- 44 days
- Class
- Class II
- Product code
- PGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120023 (2014). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN120023 Given Pillcam Colon 2 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2014
- This deviceK153466 PillCam COLON 2 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- Descendant · 3 generations on · 1 of its ownK230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023
- Descendant · 3 generations on · 0 of its ownK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK240276 PillCam™ Genius SB System with PillCam Software v9.7 and PillCam…Given Imaging Ltd. (D.B.A. Medtronic) · 2024
Most influential descendants
Showing 5 of 5 · See all- K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017 · cites it directly4descendants
- K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021 · 2 generations on3descendants
- K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023 · 3 generations on1descendant
- K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024 · 3 generations on0descendants
- K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic) · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120023 | Given Pillcam Colon 2 Capsule Endoscopy System | Given Imaging, Ltd. | 2014 | — |
| 0 (this device) | K153466 | PillCam COLON 2 Capsule Endoscopy System | Given Imaging, Ltd. | 2016 | — |
| +1 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
| +2 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| +3 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023 | — |
| +3 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024 | — |
| +4 | K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader… | Given Imaging Ltd. (D.B.A. Medtronic) | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 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
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 |
|---|---|---|---|
| * | DEN120023 | Given Pillcam Colon 2 Capsule Endoscopy SystemSummary page 4…n capsule imaging system Regulation No: 876.1330, Class: II Panel: Gastroenterology/Urology PGD- Colon Capsule Imaging System PillCam COLON 2 capsule endoscopy system (DEN 120023) Given Imaging Ltd. New Industrial Park, PO Box 258, Yokneam 20692, Israel Israel Gl‘/EN' IMAGING General Dev… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | 2017 | 4 |
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?
How does its category compare?
All PGD devicesPGD Colon Capsule Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 | — |
What is it indicated for?
The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153466: PillCam COLON 2 Capsule Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153466
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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