Biomedical Life Systems, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Biomedical Life Systems, Inc.” (first 1984, latest 2018), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 168 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 | 1 | 285 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomedical Life Systems, Inc. took a median 285 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 22 | 22 |
| IPF | Stimulator, Muscle, Powered | 7 | 7 |
| LIH | Interferential Current Therapy | 5 | 5 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 1 | 1 |
Review panels
- Neurology (30)
- Physical Medicine (7)
Most recent Biomedical Life Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172971 | BMLS16-1 | NUH | 2018-07-08 | 285 |
| K102051 | PAIN BUDDY | NUH | 2011-07-29 | 373 |
| K061476 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 | GZJ | 2006-07-26 | 57 |
| K042711 | MODEL BMLS03-7 | GZJ | 2005-03-14 | 165 |
| K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 | GZJ | 2004-11-23 | 182 |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | LIH | 2004-07-07 | 187 |
| K033174 | BMLS03-3 | IPF | 2004-06-30 | 273 |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | LIH | 2004-04-29 | 30 |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | IPF | 2004-03-23 | 43 |
| K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 | GZJ | 2004-01-15 | 77 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Life Systems, 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.
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 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 Devices, Inc. (7 510(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 Life Systems, Inc.?
FDA lists 37 510(k) clearances under the applicant name “Biomedical Life Systems, Inc.” (first 1984, latest 2018), across 5 product codes in 2 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 Life Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedical Life Systems, Inc. is 168 days.
Which FDA product codes appear under Biomedical Life Systems, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 22); IPF (Stimulator, Muscle, Powered, 7); LIH (Interferential Current Therapy, 5).
Next steps
- See all 37 Biomedical Life Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Biomedical Life Systems, 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.