Reflectance Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Reflectance Medical, Inc.” (first 2012, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 109 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 | 2 | 162 |
| 2013 | 1 | 186 |
| 2014 | 2 | 84 |
| 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 5 | 5 |
Review panels
Most recent Reflectance Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | MUD | 2014-08-04 | 59 |
| K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | MUD | 2014-04-11 | 109 |
| K130079 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER | MUD | 2013-07-19 | 186 |
| K122645 | MOBILE CAREGUIDE 2100 OXIMETER | MUD | 2012-12-05 | 97 |
| K113656 | CAREGUIDE OXIMETER | MUD | 2012-07-26 | 227 |
Recalls
openFDA lists no recalls under a recalling firm named Reflectance Medical, 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 Reflectance Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Reflectance Medical, Inc.” (first 2012, latest 2014), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reflectance Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reflectance Medical, Inc. is 109 days.
Which FDA product codes appear under Reflectance Medical, Inc.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 5).
Next steps
- See all 5 Reflectance Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Reflectance Medical, 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.