Selectivemed Components, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Selectivemed Components, Inc.” (first 1995, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 170 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 | 1 | 317 |
| 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Physical Medicine (4)
- Neurology (3)
Most recent Selectivemed Components, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | IPF | 2013-02-07 | 317 |
| K083756 | GUARDIAN 150 ELECTRODE | GXY | 2009-06-26 | 191 |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | EGJ | 2003-05-20 | 48 |
| K020476 | MEDION 6000 | EGJ | 2002-05-03 | 80 |
| K993081 | IO-DRIVE | EGJ | 2000-03-03 | 170 |
| K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES | GZJ | 1995-12-22 | 365 |
| K945676 | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES | GZJ | 1995-01-30 | 73 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-03-15.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Selectivemed Components, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Selectivemed Components, Inc.” (first 1995, latest 2013), across 4 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 Selectivemed Components, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Selectivemed Components, Inc. is 170 days.
Which FDA product codes appear under Selectivemed Components, Inc.?
The most frequent FDA product codes under this applicant name are EGJ (Device, Iontophoresis, Other Uses, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 7 Selectivemed Components, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EGJ, Selectivemed Components, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.