Company ยท GB
Flexicare Medical Limited.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| CCW | Laryngoscope, Rigid | 2 |
| OGH | Laryngoscope Kit | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| EZD | Catheter, Straight | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large P Flexicare Medical Limited., GB | EOQ |
| Jan 16, 2026 | K251448 | FL-10000U Respiratory Humidifier Flexicare Medical Limited., GB | BTT |
| May 20, 2025 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Rein Flexicare Medical Limited., GB | BTR |
| Nov 13, 2020 | K201666 | SINGLE USE MANOMETER Flexicare Medical Limited., GB | CAP |
| Mar 23, 2020 | K191909 | HepaShield Bacterial Viral Breathing System Filter Flexicare Medical Limited., GB | CAH |
| Dec 7, 2018 | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Flexicare Medical Limited., GB | BTM |
| Mar 22, 2017 | K163300 | ThermoShield HME Filter Flexicare Medical Limited., GB | CAH |
| Jul 6, 2016 | K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE Flexicare Medical Limited., GB | BTT |
| Jun 23, 2016 | K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM Flexicare Medical Limited., GB | BZE |
| May 15, 2015 | K150900 | Flexicare Heated Wire Breathing Systems Flexicare Medical, Ltd., GB | BZE |
| Apr 10, 2014 | K140473 | DUALGUARD Flexicare Medical, Ltd., GB | CCK |
| Mar 6, 2014 | K140113 | O2 NASAL CANNULA WITH CO2 MONITORING Flexicare Medical, Ltd., GB | CCK |
| Oct 11, 2013 | K132619 | CLASSIC INTERMITTENT CATHETER Flexicare Medical, Ltd., GB | EZD |
| Oct 6, 2009 | K092218 | FLEXICARE BREATHING FILTERS Flexicare Medical, Ltd., GB | CAH |
| Jun 17, 2009 | K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES Flexicare Medical, Ltd., GB | BTR |
| Apr 27, 1995 | K951652 | VENTIMASK MK IV Flexicare Medical, Ltd., GB | BYF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2020 | Flexicare Medical Ltd. ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5
*Note: product list updated per 12/23/2020 letter to customers Terminated |
BTR | K091591 |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320 Terminated |
OGH | None listed |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072
The device is intended for Terminated |
OGH | None listed |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783
The device is intended for direct vision laryngoscopy to obtain Terminated |
CCW | None listed |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001
The device is intended for direct vision laryngoscopy to obtain an Terminated |
CCW | None listed |