Data / Medical devices / Israel / Quality In Flow Ltd.
Quality In Flow Ltd.: FDA-registered device maker in PETAH TIKVA Central, Israel, 4 510(k) clearances
Quality In Flow Ltd. is registered with the FDA (registration 3013429468) in PETAH TIKVA Central, Israel. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013429468
- Address
- 23 HA-YETSIRA st., PETAH TIKVA Central, Israel, 4951251
- Owner or operator
- Quality in Flow Ltd. (10053030)
- Roles
- Manufacturer
- First device listed
- December 24, 2017
- Registered through
- 2026
- Brand names listed
- QiF device, Warrior, Warrior Blood and Fluid Warmer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Manufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 8, 2022 | K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | LGZ | Substantially Equivalent | Quality IN Flow , Ltd. | accessdata.fda.gov |
| April 27, 2018 | K180154 | QiF Blood and Fluid Warmer | LGZ | Substantially Equivalent | Quality IN Flow , Ltd. | accessdata.fda.gov |
| September 27, 2017 | K171215 | QiF Blood and Fluid Warmer | LGZ | Substantially Equivalent | Quality IN Flow , Ltd. | accessdata.fda.gov |
| April 20, 2017 | K163708 | QiF Blood and Fluid Warmer | LGZ | Substantially Equivalent | Quality IN Flow , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Warmer, Blood, Non-Electromagnetic Radiation
- All makers of Warmer, Thermal, Infusion Fluid
Updated December 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.