Data / Medical devices / United States / Estill Medical Technologies, Inc.
Estill Medical Technologies, Inc.: FDA-registered device maker in Dallas, TX, United States, 2 510(k) clearances
Estill Medical Technologies, Inc. is registered with the FDA (registration 1650754) in Dallas, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 26, 2001. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1650754
- FEI number
- 3002587972
- Address
- 5956 Sherry Ln 20th Floor, Dallas, TX, United States, 75225
- Owner or operator
- ESTILL MEDICAL TECHNOLOGIES, INC. (9036068)
- Roles
- Specification developer
- First device listed
- December 11, 2007
- Registered through
- 2026
- Brand names listed
- Thermal Angel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Specification developer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 26, 2001 | K012031 | MODIFICATION TO THERMAL ANGEL | BSB | Substantially Equivalent | Estill Medical Technologies, Inc. | accessdata.fda.gov |
| July 1, 1999 | K984640 | THERMAL ANGEL | BSB | Substantially Equivalent | Estill Medical Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2014 | 69242 | Class II | Terminated | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide suffici | Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the U | accessdata.fda.gov |
Compare with other makers
- All makers of Warmer, Blood, Non-Electromagnetic Radiation
- All makers of Warmer, Thermal, Infusion Fluid
Updated October 21, 2014. 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.