Thermacyl Blood/Fluid Warmer
FDA 510(k) K953741 · Baxter Healthcare Corp
510(k) numberK953741
Submission
- Device name
- Thermacyl Blood/Fluid Warmer
- Applicant
- Baxter Healthcare Corp
Round Lake, IL, US - Received
- August 10, 1995
- Decision date
- June 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSB – Warmer, Blood, Non-Electromagnetic Radiation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9205
- Specialty
- Hematology
Other 510(k)s with product code BSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112639 | The Belmont Buddy Lite Fluid WarmerBSB · Special | Belmont Instrument Corp. | 11/16/2011SE |
| K090508 | The Belmont Buddy Lite Fluid WarmerBSB · Special | Belmont Instrument Corp. | 03/26/2009SE |
| K062774 | Belmont Buddy Plus Fluid WarmerBSB · Special | Belmont Instrument Corp. | 10/19/2006SE |
| K052547 | Belmont Buddy Fluid WarmerBSB · Special | Belmont Instrument Corp. | 10/13/2005SE |
| K031478 | MicroheaterBSB · Traditional | Belmont Instrument Corp. | 07/02/2003SE |
| K020060 | AstofloBSB · Abbreviated | Nats Corp. | 03/05/2002SE |
| K012031 | Modification to Thermal AngelBSB · Special | Estill Medical Technologies, Inc. | 07/26/2001SE |
| K991159 | Prismatherm II, AstolineBSB · Abbreviated | Stihler Electronic GmbH | 09/03/1999SE |
| K991160 | Astotherm Plus, Astotubes, AstolineBSB · Abbreviated | Stihler Electronic GmbH | 09/02/1999SE |
| K984640 | Thermal AngelBSB · Traditional | Estill Medical Technologies, Inc. | 07/01/1999SE |
More from Estill Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Thermacyl Blood/Fluid Warmer cleared by the FDA?
Thermacyl Blood/Fluid Warmer (K953741) received a 510(k) decision of Substantially Equivalent on June 26, 1996, 321 days after the submission was received.
What is the product code of K953741?
The FDA product code is BSB – Warmer, Blood, Non-Electromagnetic Radiation, a Class II (moderate risk) device regulated under 21 CFR 864.9205.