Optical Sensors, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Optical Sensors, Inc.” (first 1993, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 226 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 |
|---|---|---|---|
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
Review panels
- Anesthesiology (6)
- Cardiovascular (1)
Most recent Optical Sensors, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040654 | SENSILASE PAD 3000 | DPW | 2004-06-04 | 84 |
| K010795 | CAPNOPROBE SL, MODEL 2000 | CCK | 2001-04-11 | 26 |
| K984579 | CAPNO PROBE A | CCK | 2000-12-21 | 729 |
| K961790 | POINT-OF-CARE BLOOD GAS MONITOR SYSTEM | CCC | 1997-04-09 | 335 |
| K963935 | OLYMPUS CRITICAL CARE MONITORING SYSTEM | CCC | 1997-01-23 | 114 |
| K951094 | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM | CCC | 1996-01-16 | 313 |
| K931185 | SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE | CCC | 1993-10-21 | 226 |
Recalls
openFDA lists no recalls under a recalling firm named Optical Sensors, 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.
- Optical Micro Systems, Inc. (21 510(k)s)
- Optical Radiation Corp. (3 510(k)s)
- Optical Connection, Inc. (2 510(k)s)
- Optical Imaging , Ltd. (2 510(k)s)
- Optical Integrity, Inc. (2 510(k)s)
- Optical Polymer Research, Inc. (2 510(k)s)
- Optical Systems Intl., Inc. (2 510(k)s)
- Optical Center (1 510(k)s)
- Optical Coating Laboratory, Inc. (1 510(k)s)
- Optical Designs and Sourcing, Inc. (1 510(k)s)
- Optical Diagnostics, Inc. (1 510(k)s)
- Optical Moulding Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Optical Sensors, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Optical Sensors, Inc.” (first 1993, latest 2004), across 3 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 Optical Sensors, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optical Sensors, Inc. is 226 days.
Which FDA product codes appear under Optical Sensors, Inc.?
The most frequent FDA product codes under this applicant name are CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2); DPW (Flowmeter, Blood, Cardiovascular, 1).
Next steps
- See all 7 Optical Sensors, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCC, Optical Sensors, 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.