Select Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Select Medical Systems, Inc.” (first 1995, latest 2001), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | 2 | 2 |
| MFD | Cannula, Intrauterine Insemination | 2 | 2 |
| HFC | Aspirator, Endocervical | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
Review panels
Most recent Select Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012935 | THECURVE, ITEM 507 | MFD | 2001-10-11 | 41 |
| K974819 | SELECTCELLS(TM) MINI | HHK | 1998-03-23 | 90 |
| K954099 | SELECT IUI | MFD | 1995-11-22 | 83 |
| K954102 | SELECTMUCUS | HFC | 1995-11-21 | 82 |
| K954097 | SELECTCELLS STANDARD | HHK | 1995-11-21 | 82 |
| K942922 | SELECTA 20/60 CHEMISTRY ANALYZER | JJE | 1995-07-19 | 393 |
Recalls
openFDA lists no recalls under a recalling firm named Select Medical 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.
- Select Sources, Inc. (7 510(k)s)
- Select Fabricators, Inc. (1 510(k)s)
- Select Labs, LLC (1 510(k)s)
- Select Medizintechnik Hermann Sutter GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Select Medical Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Select Medical Systems, Inc.” (first 1995, latest 2001), 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 Select Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Select Medical Systems, Inc. is 82 days.
Which FDA product codes appear under Select Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HHK (Curette, Suction, Endometrial (And Accessories), 2); MFD (Cannula, Intrauterine Insemination, 2); HFC (Aspirator, Endocervical, 1).
Next steps
- See all 6 Select Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HHK, Select Medical 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.