Singer Medical Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Singer Medical Products, Inc.” (first 1989, latest 1991), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 132 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 |
|---|---|---|---|
| EWO | Audiometer | 4 | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
Review panels
Most recent Singer Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | ETN | 1991-04-19 | 176 |
| K896909 | MD5 AUTOMATIC AUDIOMETER | EWO | 1990-03-05 | 84 |
| K895785 | AUDIOMETER MODEL MD-4, MD-4P | EWO | 1989-12-05 | 132 |
| K895784 | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 | EWO | 1989-12-05 | 132 |
| K895783 | IMPEDANCE ANALYZER MODELS MD-2, MD-P | ETY | 1989-12-05 | 132 |
| K894748 | IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P | EWO | 1989-12-05 | 132 |
| K896368 | MODIFIED AXOSTIM | BXN | 1989-11-27 | 21 |
| K883807 | AXOSTIM | BXN | 1989-02-09 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Singer Medical Products, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Singer Medical Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Singer Medical Products, Inc.” (first 1989, latest 1991), 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 Singer Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Singer Medical Products, Inc. is 132 days.
Which FDA product codes appear under Singer Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 4); BXN (Stimulator, Nerve, Battery-Powered, 2); ETN (Stimulator, Nerve, 1).
Next steps
- See all 8 Singer Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Singer Medical Products, 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.