Boston Medical Products, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Boston Medical Products, Inc.” (first 1980, latest 2009), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 37 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 5 | 5 |
| EMX | Balloon, Epistaxis | 4 | 4 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 4 | 4 |
| LYA | Splint, Intranasal Septal | 4 | 4 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| KCF | Dilator, Esophageal, Ent | 3 | 3 |
| NAD | Dressing, Wound, Occlusive | 2 | 2 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Boston Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | FWN | 2009-09-14 | 147 |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | MIX | 1997-09-18 | 90 |
| K972459 | RHINOCELL NASAL PACKINGS | EMX | 1997-08-04 | 34 |
| K972096 | BIVALVE NASAL SPLINT | LYA | 1997-07-15 | 41 |
| K972078 | POST-STOP EPISTAXIS CATHETER | EMX | 1997-07-10 | 37 |
| K972092 | NASAL AIRWAY SPLINT | LYA | 1997-07-08 | 34 |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | LYA | 1997-07-07 | 28 |
| K972082 | CUSTOM NASAL SPLINT | LYA | 1997-07-03 | 29 |
| K972060 | NASAL SEPTAL BUTTON | LFB | 1997-07-03 | 31 |
| K972077 | EPI-STOP EPISTAXIS CATHETER | EMX | 1997-06-26 | 23 |
23 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Medical Products, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Boston Medical Products, Inc.” (first 1980, latest 2009), across 15 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Boston Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Medical Products, Inc. is 37 days.
Which FDA product codes appear under Boston Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 5); EMX (Balloon, Epistaxis, 4); FWN (Prosthesis, Larynx (Stents And Keels), 4).
Next steps
- See all 33 Boston Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Boston Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.