The Belmont Buddy Lite Fluid Warmer
FDA 510(k) K112639 · Belmont Instrument Corp.
510(k) numberK112639
Submission
- Device name
- The Belmont Buddy Lite Fluid Warmer
- Applicant
- Belmont Instrument Corp.
Billerica, MA, US - Received
- September 12, 2011
- Decision date
- November 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | Augustine Medical, Inc. | 04/30/1998SE |
More from Augustine Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152208 | The Belmont Hyperthermia PumpLGZ · Special | 09/02/2015SE |
| K141654 | The Belmont Rapid InfuserFRN · Special | 07/18/2014SE |
| K131519 | Belmont Hyperthermia PumpLGZ · Special | 11/06/2013SE |
| K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000FRN · Special | 07/01/2009SE |
| K090508 | The Belmont Buddy Lite Fluid WarmerBSB · Special | 03/26/2009SE |
| K090089 | Belmont Hyperthermia PumpLGZ · Special | 02/12/2009SE |
| K070654 | Hyperthermia PumpLGZ · Traditional | 06/08/2007SE |
| K062774 | Belmont Buddy Plus Fluid WarmerBSB · Special | 10/19/2006SE |
| K052547 | Belmont Buddy Fluid WarmerBSB · Special | 10/13/2005SE |
| K032778 | Large Volume Fluid ReservoirLGZ · Special | 09/22/2003SE |
Questions and answers
When was The Belmont Buddy Lite Fluid Warmer cleared by the FDA?
The Belmont Buddy Lite Fluid Warmer (K112639) received a 510(k) decision of Substantially Equivalent on November 16, 2011, 65 days after the submission was received.
What is the product code of K112639?
The FDA product code is BSB – Warmer, Blood, Non-Electromagnetic Radiation, a Class II (moderate risk) device regulated under 21 CFR 864.9205.