510(k) · Cleared
ClearedRAPID Web
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 May 26, 2017 as substantially equivalent to K123864 (Given Imaging, Ltd., 2013) after a 66-day review. Its family tree reaches back 16 generations to 2001.
- Decided
- May 26, 2017
- Review
- 66 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to DEN010002 (2001). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 12 generations between
- 3 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 2 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 1 generation backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- This deviceK170839 RAPID WebGiven Imaging, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 15 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 14 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 13 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 12 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 11 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 10 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 9 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 8 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 7 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 6 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 5 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 4 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 3 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 2 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 1 generation backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- This deviceK170839 RAPID WebGiven Imaging, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −15 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −14 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −13 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −12 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −11 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −10 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −9 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −8 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −7 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −6 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −5 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −4 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −3 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| −2 | K101250 | Given Pillcam Platform with Pillcam SB Capsules | Given Imaging, Ltd. | 2011 | — |
| −1 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
| 0 (this device) | K170839 | RAPID Web | Given Imaging, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 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 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 |
|---|---|---|---|
| * | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemSummary page 6…I PGD - colon capsule imaging system, class II III. PREDICATE DEVICES RAPID 8.0 Software (K123864) Reference Devices: UGI Capsule (K140284) and COLON 2 Capsule (K153466) IV. DEVICE DESCRIPT… | 2013 |
| † | K140284 | Given Pillcam Ugi Capsule Endoscopy System | 2014 |
| † | K153466 | PillCam COLON 2 Capsule Endoscopy System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 20 ancestors has a recall.
- 5 other devices also cite its predicate K123864.
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. 2017, 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?
With PillCam SB 2 and SB 3 Capsules The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa. PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in…
Read the full statement (395 words)
With PillCam SB 2 and SB 3 Capsules
The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
With PillCam ESO 3 Capsule
The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.
With PillCam UGI Capsule
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.
With PillCam COLON Capsule
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 GI 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 as stated in the FDA summary.
https://510kreport.com/device/K170839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170839: RAPID Web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170839
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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