Somanetics Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Somanetics Corp.” (first 1990, latest 2010), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 137 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 |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| MUD | Oximeter, Tissue Saturation | 4 | 4 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 3 | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
Most recent Somanetics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093422 | VITAL SYNC MODEL 5000 SERIES | MWI | 2010-04-29 | 177 |
| K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | MUD | 2009-07-09 | 73 |
| K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | MUD | 2009-04-03 | 232 |
| K080769 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C | MUD | 2008-05-14 | 57 |
| K051274 | INVOS SYSTEM | MUD | 2005-11-04 | 171 |
| K040162 | CORRESTORE PATCH SYSTEM | DXZ | 2004-03-16 | 50 |
| K031586 | CORRESTORE PATCH SYSTEM | DXZ | 2003-08-07 | 78 |
| K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS | DXZ | 2001-11-21 | 190 |
| K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 | DQA | 2000-09-15 | 88 |
| K971628 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | DQA | 1997-10-10 | 161 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Somanetics Corp..
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 Somanetics Corp.?
FDA lists 12 510(k) clearances under the applicant name “Somanetics Corp.” (first 1990, latest 2010), across 4 product codes in 3 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 Somanetics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somanetics Corp. is 137 days.
Which FDA product codes appear under Somanetics Corp.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); MUD (Oximeter, Tissue Saturation, 4); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 3).
Next steps
- See all 12 Somanetics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Somanetics Corp.'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.