510(k) · Cleared
Recalled · 2011Pillcam Express Video Capsules Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging, Ltd. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Sep 30, 2010 as substantially equivalent to K040494 (United States Endoscopy Group, Inc., 2004) after a 154-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Sep 30, 2010
- Review
- 154 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040494 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040494 Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery…United States Endoscopy Group, Inc. · 2004
- This deviceK101200 Pillcam Express Video Capsules Delivery DeviceGiven Imaging, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040494 | Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM… | United States Endoscopy Group, Inc. | 2004 | — |
| 0 (this device) | K101200 | Pillcam Express Video Capsules Delivery Device | Given Imaging, Ltd. | 2010 | — |
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 NEZ? 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 NEZ device
- #1 K252617 MiroCam® Capsule Endoscope Systemscore 17.0 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K040494 | Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM, Model 711144Summary page 1…astrointestinal, Wireless, Capsule and KOG - Endoscope and/or accessories Predicate Device(s): Capsule endoscopy delivery device (K040494) (Ilvcn I mingi ng Lt.d. Nc\\ Irdustrial Park. 1PD Box 258, Yncjncanm 206'2. Israel… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2011 | Not classified | Z-1748-2011 | Device Design | The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NEZ devicesNEZ System, Imaging, Gastrointestinal, Wireless, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NEZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEZ
99in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEZ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEZ
69in 2025
MAUDE reports naming product code NEZ, 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 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 3 | 213 | 1 | 10 |
| 2012 | 1 | — | 0 | 19 |
| 2013 | 3 | 194 | 0 | 6 |
| 2014 | 3 | 194 | 0 | 13 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 2 | — | 0 | 57 |
| 2017 | 4 | 83 | 0 | 55 |
| 2018 | 3 | 233 | 0 | 50 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 3 | 99 | 0 | 103 |
| 2025 | 1 | — | 0 | 69 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101200: Pillcam Express Video Capsules Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101200
Report an extraction error
Are you the manufacturer?
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