Medical Device Manufacturer · GB , Mountain Ash

Flexicare Medical Limited.

8 submissions · 8 cleared · Since 2016
8
Total
8
Cleared
0
Denied

Flexicare Medical Limited. — FDA 510(k) Submissions

Flexicare Medical Limited. has submitted 8 FDA 510(k) premarket notifications since 2016, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Filter, Bacterial, Breathing-circuit, Humidifier, Respiratory Gas, (direct Patient Interface), Ventilator, Emergency, Manual (resuscitator), Monitor, Airway Pressure (includes Gauge And/or Alarm), Tube, Tracheal (w/wo Connector) . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
FL-10000U Respiratory Humidifier
K251448 · BTT Humidifier, Respiratory... · Anesthesiology
Jan 2026 252d
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)
K250243 · BTR Tube, Tracheal (w/wo... · Anesthesiology
May 2025 113d
SINGLE USE MANOMETER
K201666 · CAP Monitor, Airway Pressure... · Anesthesiology
Nov 2020 147d
HepaShield Bacterial Viral Breathing System Filter
K191909 · CAH Filter, Bacterial,... · General Hospital
Mar 2020 250d
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
K181583 · BTM Ventilator, Emergency,... · Anesthesiology
Dec 2018 175d
ThermoShield HME Filter
K163300 · CAH Filter, Bacterial,... · General Hospital
Mar 2017 120d
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
K161314 · BTT Humidifier, Respiratory... · Anesthesiology
Jul 2016 56d
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
K160540 · BZE Heater, Breathing System... · Anesthesiology
Jun 2016 118d
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