Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boddingtons Plastics, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
260 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191330 | Arc Enterocuff | Boddingtons Plastics, Ltd. | 2020-01-31 | 260 | 0 |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. | 2019-05-30 | 38 | 0 |
| K162205 | Arc EndoCuff and Arc EndoCuff Vision | Boddingtons Plastics, Ltd. | 2016-12-09 | 126 | 0 |
| K151801 | Arc Endocuff Vision | Boddingtons Plastics, Ltd. | 2015-08-13 | 42 | 0 |
| K122565 | ARC ENDOCUFF | Boddingtons Plastics, Ltd. | 2012-09-04 | 13 | 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