Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Given Imaging , Ltd. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
316 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180171 | PillCam Patency System | Given Imaging , Ltd. | 2018-03-08 | 45 | 0 |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Softwar | Given Imaging , Ltd. | 2017-09-01 | 220 | 0 |
| K170839 | RAPID Web | Given Imaging , Ltd. | 2017-05-26 | 66 | 0 |
| K151086 | ManoScan System | Given Imaging , Ltd. | 2016-04-28 | 372 | 0 |
| K153466 | PillCam COLON 2 Capsule Endoscopy System | Given Imaging , Ltd. | 2016-01-14 | 44 | 0 |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2014-12-17 | 316 | 0 |
| DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2014-01-29 | 426 | 0 |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM | Given Imaging , Ltd. | 2013-08-12 | 238 | 0 |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFO | Given Imaging , Ltd. | 2011-05-13 | 213 | 0 |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | Given Imaging , Ltd. | 2011-03-07 | 307 | 0 |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM | Given Imaging , Ltd. | 2011-01-14 | 87 | 0 |
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Given Imaging , Ltd. | 2010-12-01 | 89 | 2 |
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | Given Imaging , Ltd. | 2010-09-30 | 154 | 1 |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULE | Given Imaging , Ltd. | 2009-09-28 | 210 | 0 |
| K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSO | Given Imaging , Ltd. | 2009-07-29 | 78 | 0 |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | 2007-06-11 | 47 | 0 |
| K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | Given Imaging , Ltd. | 2007-05-07 | 76 | 0 |
| K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-10-18 | 30 | 0 |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-24 | 61 | 0 |
| K053639 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-08 | 129 | 0 |
| K052184 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2005-12-01 | 112 | 0 |
| K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | Given Imaging , Ltd. | 2004-11-24 | 28 | 0 |
| K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | Given Imaging , Ltd. | 2004-10-25 | 175 | 0 |
| K040248 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2004-02-17 | 14 | 0 |
| K032405 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-10-29 | 86 | 0 |
| K031033 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-07-01 | 91 | 0 |
| K022980 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-02-27 | 171 | 0 |
| K022362 | GIVEN DIAGNOSTICS SYSTEM | Given Imaging , Ltd. | 2002-08-09 | 18 | 0 |
| K020341 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2002-05-02 | 90 | 0 |
| DEN010002 | GIVEN DIAGNOSTIC IMAGING SYSTEM | Given Imaging , Ltd. | 2001-08-01 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda