Product code BSB— Hematology
THE BELMONT BUDDY LITE FLUID WARMER
- Classification name
- Warmer, Blood, Non-Electromagnetic Radiation
- Device class
- Class 2
- Regulation
- 21 CFR 864.9205
- Advisory panel
- Hematology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code BSB
FDA has cleared devices under product code BSB between 1976 and 2011, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2009
- 2006
- 2005
- 2003
- 2002
- 2001
- 1999
- 1998
- 1996
- 1977
- 1976
Top applicants under product code BSB
Adverse events under product code BSB
product code BSB- Death
- 5
- Malfunction
- 1,778
- Total
- 1,783
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code BSB
- K112639 — THE BELMONT BUDDY LITE FLUID WARMER
- K090508 — THE BELMONT BUDDY LITE FLUID WARMER
- K062774 — BELMONT BUDDY PLUS FLUID WARMER
- K052547 — BELMONT BUDDY FLUID WARMER
- K031478 — MICROHEATER
- K020060 — ASTOFLO
- K012031 — MODIFICATION TO THERMAL ANGEL
- K991159 — PRISMATHERM II, ASTOLINE
- K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
- K984640 — THERMAL ANGEL
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K953741 — THERMACYL BLOOD/FLUID WARMER
- K770232 — BLOOD/FLUID WARMER MODEL DW-1000A
- K760012 — BLOOD WARMER (CODE 4R4305)
Data sourced from openFDA. This site is unofficial and independent of the FDA.