Biomedical Devices, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biomedical Devices, Inc.” (first 1983, latest 1995), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| FXY | Hood, Surgical | 2 | 2 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
Most recent Biomedical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955439 | THE REEL THING (MODIFICATION) | GBX | 1995-12-26 | 43 |
| K931847 | BIO-PREP CEMENT RESTRICTOR | LZN | 1994-06-28 | 441 |
| K931846 | BIO-PREP | LXH | 1994-01-21 | 283 |
| K925982 | BMD AIR/OXYGEN BLENDER | BZR | 1993-10-07 | 316 |
| K903533 | STERI-SHIELD | FXY | 1990-10-19 | 74 |
| K902677 | STERI-SHIELD | FXY | 1990-08-17 | 60 |
| K830605 | PUMP PALL AMBULATORY INSULIN INFUSION | FRN | 1983-03-31 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Devices, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biomedical Devices, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Biomedical Life Systems, Inc. (37 510(k)s)
- Biomedical Ent., Inc. (13 510(k)s)
- Biomedical Diagnostics (Bmd) SA (10 510(k)s)
- Biomedical Dynamics, Inc. (10 510(k)s)
- Biomedical Enterprises, Inc. (10 510(k)s)
- Biomedical Concepts, Inc. (3 510(k)s)
- Biomedical Design Instruments (3 510(k)s)
- Biomedical Research & Development Laboratories, Inc. (3 510(k)s)
- Biomedical Sensors, Inc. (3 510(k)s)
- Biomedical Systems Corp. (3 510(k)s)
- Biomedical Composites, Ltd. (2 510(k)s)
- Biomedical Exports, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomedical Devices, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Biomedical Devices, Inc.” (first 1983, latest 1995), across 6 product codes in 4 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 Biomedical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedical Devices, Inc. is 74 days.
Which FDA product codes appear under Biomedical Devices, Inc.?
The most frequent FDA product codes under this applicant name are FXY (Hood, Surgical, 2); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 1); FRN (Pump, Infusion, 1).
Next steps
- See all 7 Biomedical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXY, Biomedical Devices, 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.