# Flexicare Medical Limited.

- Location (FDA's records): Mountain Ash, GB
- FDA decisions: 16 (1995–2026): 16 510(k) clearances
- Names in FDA's records: Flexicare Medical Limited. (9); Flexicare Medical, Ltd. (7)
- Product codes: CAH (3), BTT (2), CCK (2), BTR (2), BZE (2), BTM (1), EZD (1), BYF (1), CAP (1), EOQ (1)
- 510(k) review time since 2016: median 118 days, against 206 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 18 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fisher & Paykel Healthcare, Ltd.: 3 (https://510kreport.com/company/fisher-paykel-healthcare)
- Ambu, Inc.: 3 (https://510kreport.com/company/ambu)
- Fisher & Paykel Electronics, Ltd.: 2 (https://510kreport.com/company/fisher-paykel-electronics)
- Gibeck, Inc.: 2 (https://510kreport.com/company/gibeck)
- Pall Medical: 1 (https://510kreport.com/company/pall-medical)
- Hospitak, Inc.: 1 (https://510kreport.com/company/hospitak)
- Etview, Ltd.: 1 (https://510kreport.com/company/etview)
- Biosearch Medical Products, Inc.: 1 (https://510kreport.com/company/biosearch-medical-products)

## Firms that cite its devices most
- Great Group Medical Co, Ltd.: 2 (https://510kreport.com/company/great-group-medical)
- Drägerwerk AG & Co. KGaA: 1 (https://510kreport.com/company/dragerwerk-ag-co-kgaa)
- Inventeur, LLC: 1 (https://510kreport.com/company/inventeur)
- Besmed Health Business Corp: 1 (https://510kreport.com/company/besmed-health-business)

## Its most-cited devices
- K191909: HepaShield Bacterial Viral Breathing System Filter (2020), cited by 2
- K163300: ThermoShield HME Filter (2017), cited by 2
- K161314: Flexicare FL-9000U Respiratory Humidifier Base (2016), cited by 1
- K140473: Dualguard (2014), cited by 1

## Recent decisions
- 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) (Sep 2, 2026)
- K251448: FL-10000U Respiratory Humidifier (Jan 16, 2026)
- 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) (May 20, 2025)
- K201666: Single Use Manometer (Nov 13, 2020)
- K191909: HepaShield Bacterial Viral Breathing System Filter (Mar 23, 2020)
- 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 (Dec 7, 2018)
- K163300: ThermoShield HME Filter (Mar 22, 2017)
- K161314: Flexicare FL-9000U Respiratory Humidifier Base (Jul 6, 2016)

Source page: https://510kreport.com/company/flexicare-medical