Flexicare Medical Limited.: FDA clearances and approvals
Flexicare Medical Limited. has 9 FDA 510(k) clearances (first 2016, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time: 147 days. Since 2017 its median was 175 days, against 197 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 87 |
| 2017 | 1 | 120 |
| 2018 | 1 | 175 |
| 2019 | 0 | — |
| 2020 | 2 | 198 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 113 |
| 2026 | 2 | 256 |
Review time against the same product codes
Since 2017, Flexicare Medical Limited.'s cleared 510(k)s took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent Flexicare Medical Limited. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | EOQ | 2026-09-02 | 260 |
| K251448 | FL-10000U Respiratory Humidifier | BTT | 2026-01-16 | 252 |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | 2025-05-20 | 113 |
| K201666 | SINGLE USE MANOMETER | CAP | 2020-11-13 | 147 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | 2020-03-23 | 250 |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | BTM | 2018-12-07 | 175 |
| K163300 | ThermoShield HME Filter | CAH | 2017-03-22 | 120 |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | BTT | 2016-07-06 | 56 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | BZE | 2016-06-23 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Flexicare Medical Limited..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Flexicare Medical Limited. have?
Flexicare Medical Limited. has 9 FDA 510(k) clearances (first 2016, latest 2026), across 7 product codes in 3 review panels.
How long does FDA take to clear Flexicare Medical Limited.'s 510(k)s?
The median time from FDA receipt to decision across Flexicare Medical Limited.'s cleared 510(k)s is 147 days. Since 2017: 175 days, versus 197 days for all cleared 510(k)s in the same product codes.
What devices does Flexicare Medical Limited. make?
Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2); CAH (Filter, Bacterial, Breathing-Circuit, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Has Flexicare Medical Limited. had device recalls?
openFDA lists no recalls under a recalling firm name matching Flexicare Medical Limited. Related entities may recall under other names.
Next steps
- See all 9 Flexicare Medical Limited. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Flexicare Medical Limited.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.