Philosys, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Philosys, Inc.” (first 2013, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 455 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 |
|---|---|---|
| 2013 | 1 | 455 |
| 2014 | 1 | 461 |
| 2015 | 3 | 286 |
| 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
Review panels
Most recent Philosys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151658 | Gmate Origin Blood Glucose Monitoring System | NBW | 2015-12-01 | 165 |
| K150299 | Gmate SMART Blood Glucose Monitoring System | NBW | 2015-11-19 | 286 |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2015-10-02 | 469 |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | NBW | 2014-08-04 | 461 |
| K113636 | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | CGA | 2013-03-08 | 455 |
Recalls
openFDA lists no recalls under a recalling firm named Philosys, 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 Philosys, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Philosys, Inc.” (first 2013, latest 2015), across 2 product codes 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 Philosys, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philosys, Inc. is 455 days.
Which FDA product codes appear under Philosys, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 4); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 5 Philosys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Philosys, 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.