Blood Warmer (Code 4R4305)
FDA 510(k) K760012 · Travenol Laboratories, S.A.
510(k) numberK760012
Submission
- Device name
- Blood Warmer (Code 4R4305)
- Applicant
- Travenol Laboratories, S.A.
Mchenry, IL, US - Received
- June 10, 1976
- Decision date
- July 16, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
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| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
Questions and answers
When was Blood Warmer (Code 4R4305) cleared by the FDA?
Blood Warmer (Code 4R4305) (K760012) received a 510(k) decision of Substantially Equivalent on July 16, 1976, 36 days after the submission was received.
What is the product code of K760012?
The FDA product code is BSB – Warmer, Blood, Non-Electromagnetic Radiation, a Class II (moderate risk) device regulated under 21 CFR 864.9205.