510(k) · Cleared
ClearedCapsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM, Model 711144
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Jun 23, 2004 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 23, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040494 Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery…United States Endoscopy Group, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK101200 Pillcam Express Video Capsules Delivery DeviceGiven Imaging, Ltd. · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K101200Pillcam Express Video Capsules Delivery DeviceGiven Imaging, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040494 | Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM… | United States Endoscopy Group, Inc. | 2004 | — |
| +1 | K101200 | Pillcam Express Video Capsules Delivery Device | Given Imaging, Ltd. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K101200 | Pillcam Express Video Capsules Delivery Device | 2010 | 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?
- Of its descendants, K101200 (Given Imaging, Ltd., 2010) has gone furthest, with 0 descendants of its own.
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.
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 Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040494 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040494: Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM, Model 711144.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040494
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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