Solaris Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Solaris Medical Technology, Inc.” (first 2007, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 208 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 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
- Anesthesiology (4)
- Cardiovascular (1)
Most recent Solaris Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100077 | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 | DQA | 2010-10-07 | 268 |
| K101972 | SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS | DXQ | 2010-07-22 | 9 |
| K092950 | SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES | DQA | 2010-03-12 | 169 |
| K073249 | SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES | DQA | 2008-07-25 | 249 |
| K061931 | SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 | DQA | 2007-01-31 | 208 |
Recalls
openFDA lists no recalls under a recalling firm named Solaris Medical Technology, 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 Solaris Medical Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Solaris Medical Technology, Inc.” (first 2007, latest 2010), across 2 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 Solaris Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solaris Medical Technology, Inc. is 208 days.
Which FDA product codes appear under Solaris Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 5 Solaris Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Solaris Medical Technology, 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.