Flexicare Medical Limited.
Medical device manufacturer in Rhondda Cynon Taf, GB.
16510(k) clearances
0PMA approvals
5recalls
Device types
- CAH Filter, Bacterial, Breathing-Circuit 3
- BTR Tube, Tracheal (W/Wo Connector) 2
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 2
- BZE Heater, Breathing System W/Wo Controller… 2
- BTT Humidifier, Respiratory Gas, (Direct… 2
- BYF Mask, Oxygen, Low Concentration, Venturi 1
- EZD Catheter, Straight 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- CAP Monitor, Airway Pressure (Includes Gauge… 1
- EOQ Bronchoscope (Flexible Or Rigid) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | 09/02/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | 01/16/2026SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | 05/20/2025SE |
| K201666 | Single Use ManometerCAP · Traditional | 11/13/2020SE |
| K191909 | HepaShield Bacterial Viral Breathing System FilterCAH · Traditional | 03/23/2020SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | 12/07/2018SE |
| K163300 | ThermoShield HME FilterCAH · Traditional | 03/22/2017SE |
| K161314 | Flexicare FL-9000U Respiratory Humidifier BaseBTT · Traditional | 07/06/2016SE |
| K160540 | Flexicare Neonatal Heated Wire Breathing SystemBZE · Traditional | 06/23/2016SE |
| K150900 | Flexicare Heated Wire Breathing SystemsBZE · Traditional | 05/15/2015SE |
| K140473 | DualguardCCK · Traditional | 04/10/2014SE |
| K140113 | O2 Nasal Cannula with CO2 MonitoringCCK · Traditional | 03/06/2014SE |
| K132619 | Classic Intermittent CatheterEZD · Traditional | 10/11/2013SE |
| K092218 | Flexicare Breathing FiltersCAH · Traditional | 10/06/2009SE |
| K091591 | Flexicare Medical Endotracheal TubesBTR · Traditional | 06/17/2009SE |
| K951652 | Ventimask MK IVBYF · Traditional | 04/27/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0497-2021 Class I | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/…When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of… | 09/22/2020Terminated |
| Z-0804-2020 Class II | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | 11/27/2019Terminated |
| Z-0803-2020 Class II | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | 11/27/2019Terminated |
| Z-0802-2020 Class II | BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | 11/27/2019Terminated |
| Z-0801-2020 Class II | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | 11/27/2019Terminated |