Home / 510(k) Clearances / K070654

510(k) K070654

HYPERTHERMIA PUMP by Belmont Instrument Corp. — Product Code LGZ

K070654 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "HYPERTHERMIA PUMP". The FDA issued a decision of Substantially Equivalent on June 8, 2007. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Belmont Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2007
Date Received
March 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Belmont Instrument Corp.

  • K131519 — BELMONT HYPERTHERMIA PUMP (November 6, 2013)
  • K112639 — THE BELMONT BUDDY LITE FLUID WARMER (November 16, 2011)
  • K091855 — THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 (July 1, 2009)
  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K090089 — BELMONT HYPERTHERMIA PUMP (February 12, 2009)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K032778 — LARGE VOLUME FLUID RESERVOIR (September 22, 2003)
  • K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (September 16, 2003)
  • K031478 — MICROHEATER (July 2, 2003)

Other clearances for product code LGZ

  • K262532 — NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, (September 18, 2026)
  • K260988 — °M Warmer System with °M Station (April 24, 2026)
  • K252636 — Fluido Compact System (November 18, 2025)
  • K251733 — Fluido® AirGuard System (September 4, 2025)
  • K232107 — °M Warmer System (May 31, 2024)
  • K211618 — Fluido Compact Blood and Fluid Warming System (June 5, 2023)
  • K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior (December 8, 2022)
  • K202461 — ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion Sys (August 12, 2022)
  • K213191 — S-Line (May 24, 2022)
  • K192325 — Quantum Blood and Fluid Warming System (October 18, 2019)

FDA data resources