Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NSI — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
210 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180171 | PillCam Patency System | Given Imaging , Ltd. | 2018-03-08 | 45 | 0 |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULE | Given Imaging , Ltd. | 2009-09-28 | 210 | 0 |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | 2007-06-11 | 47 | 0 |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-24 | 61 | 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 |
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