Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bridgepoint Medical · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
305 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122795 | STINGRAY GUIDEWIRES | Bridgepoint Medical | 2012-11-08 | 57 | 0 |
| K121745 | MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-07-13 | 29 | 0 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-05-22 | 90 | 0 |
| K120881 | MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-04-18 | 26 | 0 |
| K120129 | MANTARAY CATHETER | Bridgepoint Medical | 2012-02-03 | 17 | 0 |
| K113589 | BIGBOSS CATHETER | Bridgepoint Medical | 2012-01-04 | 30 | 0 |
| K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | Bridgepoint Medical | 2011-08-10 | 30 | 0 |
| K111488 | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 | Bridgepoint Medical | 2011-06-30 | 30 | 0 |
| K101591 | STINGRAY ORIENTING BALLOON CATHETER | Bridgepoint Medical | 2010-08-06 | 60 | 1 |
| K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | Bridgepoint Medical | 2009-09-02 | 72 | 0 |
| K081130 | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER | Bridgepoint Medical | 2009-05-14 | 388 | 0 |
| K083727 | STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M- | Bridgepoint Medical | 2009-02-20 | 67 | 0 |
| K080987 | BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES | Bridgepoint Medical | 2009-02-06 | 305 | 1 |
| K081187 | BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHE | Bridgepoint Medical | 2008-10-08 | 163 | 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