Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Boston Medical Products, Inc. · Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
148 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | Boston Medical Products, Inc. | 2009-09-14 | 147 | 0 |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | Boston Medical Products, Inc. | 1997-09-18 | 90 | 0 |
| K972459 | RHINOCELL NASAL PACKINGS | Boston Medical Products, Inc. | 1997-08-04 | 34 | 0 |
| K972096 | BIVALVE NASAL SPLINT | Boston Medical Products, Inc. | 1997-07-15 | 41 | 0 |
| K972078 | POST-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-07-10 | 37 | 0 |
| K972092 | NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | 1997-07-08 | 34 | 0 |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | 1997-07-07 | 28 | 0 |
| K972060 | NASAL SEPTAL BUTTON | Boston Medical Products, Inc. | 1997-07-03 | 31 | 0 |
| K972082 | CUSTOM NASAL SPLINT | Boston Medical Products, Inc. | 1997-07-03 | 29 | 0 |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 | 23 | 0 |
| K972077 | EPI-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 | 23 | 0 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 | 148 | 0 |
| K962240 | MOORE TRACHEOSTOMY TUBE | Boston Medical Products, Inc. | 1996-08-15 | 65 | 0 |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | Boston Medical Products, Inc. | 1996-08-09 | 29 | 0 |
| K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | Boston Medical Products, Inc. | 1996-07-25 | 14 | 0 |
| K955634 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | Boston Medical Products, Inc. | 1996-06-10 | 182 | 0 |
| K960450 | HEBELER SAFE-T-TUBE | Boston Medical Products, Inc. | 1996-04-19 | 80 | 0 |
| K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | Boston Medical Products, Inc. | 1995-12-22 | 18 | 0 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 | 82 | 0 |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | 1993-05-18 | 336 | 0 |
| K930150 | SAFE-T-TUBE RADIOPAQUE | Boston Medical Products, Inc. | 1993-02-12 | 39 | 0 |
| K923355 | PHARYNGEAL SALIVARY BYPASS TUBE | Boston Medical Products, Inc. | 1992-10-06 | 90 | 0 |
| K912290 | HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) | Boston Medical Products, Inc. | 1991-08-26 | 95 | 0 |
| K910618 | SUH VENT TUBE | Boston Medical Products, Inc. | 1991-06-28 | 136 | 0 |
| K903876 | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) | Boston Medical Products, Inc. | 1991-02-04 | 166 | 0 |
| K880720 | MONTGOMERY NERVE STIMULATOR | Boston Medical Products, Inc. | 1988-05-20 | 87 | 0 |
| K843936 | MONTGOMERY SAFE-T-TUBE | Boston Medical Products, Inc. | 1984-12-14 | 66 | 0 |
| K842800 | MONTG. LARYNGEAL KEEL | Boston Medical Products, Inc. | 1984-08-02 | 16 | 0 |
| K842287 | MONTGOMERY LARYNGEAL STENT | Boston Medical Products, Inc. | 1984-06-27 | 12 | 0 |
| K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | Boston Medical Products, Inc. | 1981-09-08 | 22 | 0 |
| K810978 | MONTGOMERY SILICONE TRACHEAL T-TUBE | Boston Medical Products, Inc. | 1981-05-05 | 25 | 0 |
| K802915 | MONTG. TRACHEAL TREPHINE FENE STRATOR | Boston Medical Products, Inc. | 1980-12-19 | 30 | 0 |
| K802916 | MONTG. TRACHEAL CANNULA | Boston Medical Products, Inc. | 1980-12-19 | 30 | 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