Boston Pacific Medical, Inc.: FDA clearances and approvals
Boston Pacific Medical, Inc. has 11 FDA 510(k) clearances (first 1992, latest 1994), across 10 product codes in 3 review panels. Median 510(k) review time: 350 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZD | Catheter, Straight | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| EZQ | Pouch, Colostomy | 1 | 1 |
| FCE | Enema Kit | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| KMO | Binder, Elastic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Review panels
Most recent Boston Pacific Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | KOD | 1994-03-28 | 276 |
| K922402 | 4 SURE TM ENTERAL FEEDING BAG | FPD | 1994-03-25 | 673 |
| K931048 | 4-SURE NELATON CATHETER | EZD | 1994-02-14 | 350 |
| K931047 | 4-SURE FEMALE CATHETER | EZD | 1994-02-14 | 350 |
| K921852 | 4 SURE TM RECTAL TUBE | KMO | 1993-10-08 | 539 |
| K921853 | 4 SURE TM FEEDING TUBES | KNT | 1993-07-13 | 452 |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | BSY | 1993-07-07 | 446 |
| K922398 | 4 SURE TM ENEMA BAG SET | FCE | 1993-06-17 | 392 |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | CAT | 1993-03-18 | 301 |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | BSO | 1992-12-30 | 90 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Boston Pacific Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Boston Pacific Medical, Inc. have?
Boston Pacific Medical, Inc. has 11 FDA 510(k) clearances (first 1992, latest 1994), across 10 product codes in 3 review panels.
How long does FDA take to clear Boston Pacific Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Boston Pacific Medical, Inc.'s cleared 510(k)s is 350 days.
What devices does Boston Pacific Medical, Inc. make?
Its most frequent FDA product codes are EZD (Catheter, Straight, 2); BSO (Catheter, Conduction, Anesthetic, 1); BSY (Catheters, Suction, Tracheobronchial, 1).
Has Boston Pacific Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Boston Pacific Medical, Inc. Related entities may recall under other names.
Next steps
- See all 11 Boston Pacific Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZD, Boston Pacific Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.