Prismatherm II, Astoline
FDA 510(k) K991159 · Stihler Electronic GmbH
510(k) numberK991159
Submission
- Device name
- Prismatherm II, Astoline
- Applicant
- Stihler Electronic GmbH
Sound Beach, NY, US - Received
- April 7, 1999
- Decision date
- September 3, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | 07/08/2026SE |
| K202197 | Astopad Patient Warming SystemDWJ · Traditional | 09/04/2020SE |
| K082758 | Prismaflo IIKOC · Special | 12/19/2008SE |
| K082765 | Astoflo PlusLGZ · Traditional | 12/18/2008SE |
| K020103 | PrismafloKOC · Abbreviated | 07/24/2002SE |
| K991160 | Astotherm Plus, Astotubes, AstolineBSB · Abbreviated | 09/02/1999SE |
Questions and answers
When was Prismatherm II, Astoline cleared by the FDA?
Prismatherm II, Astoline (K991159) received a 510(k) decision of Substantially Equivalent on September 3, 1999, 149 days after the submission was received.
What is the product code of K991159?
The FDA product code is BSB – Warmer, Blood, Non-Electromagnetic Radiation, a Class II (moderate risk) device regulated under 21 CFR 864.9205.