Flexicare Medical, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Flexicare Medical, Ltd.” (first 1995, latest 2015), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 44 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 | 1 | 51 |
| 2014 | 2 | 47 |
| 2015 | 1 | 42 |
| 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
Review panels
Most recent Flexicare Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150900 | Flexicare Heated Wire Breathing Systems | BZE | 2015-05-15 | 42 |
| K140473 | DUALGUARD | CCK | 2014-04-10 | 44 |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | CCK | 2014-03-06 | 50 |
| K132619 | CLASSIC INTERMITTENT CATHETER | EZD | 2013-10-11 | 51 |
| K092218 | FLEXICARE BREATHING FILTERS | CAH | 2009-10-06 | 76 |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | BTR | 2009-06-17 | 15 |
| K951652 | VENTIMASK MK IV | BYF | 1995-04-27 | 17 |
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-09-22.
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.
- Flexicare Medical Limited. (9 510(k)s)
- Flexicare (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Flexicare Medical, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Flexicare Medical, Ltd.” (first 1995, latest 2015), across 6 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 Flexicare Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Flexicare Medical, Ltd. is 44 days.
Which FDA product codes appear under Flexicare Medical, Ltd.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2); BTR (Tube, Tracheal (W/Wo Connector), 1); BYF (Mask, Oxygen, Low Concentration, Venturi, 1).
Next steps
- See all 7 Flexicare Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Flexicare Medical, Ltd.'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.