BLOOD/FLUID WARMER MODEL DW-1000A— 510(k) K770232

Clearance details

Applicant

Gorman Rupp Industries

Product code

Code BSB

Device class

Class 2

Regulation

21 CFR 864.9205

Advisory panel

Hematology

Date received

1977-02-07

Decision date

1977-02-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K112639 — THE BELMONT BUDDY LITE FLUID WARMER2011-11-16
• K090508 — THE BELMONT BUDDY LITE FLUID WARMER2009-03-26
• K062774 — BELMONT BUDDY PLUS FLUID WARMER2006-10-19
• K052547 — BELMONT BUDDY FLUID WARMER2005-10-13
• K031478 — MICROHEATER2003-07-02

• K771537 — AQUAMATIC K-MODULE MODEL K-201977-09-06
• K770839 — AQUAMATIC K-771977-06-08
• K761337 — AQUAMATIC K-MODULE MODEL K-101977-01-10
• K760910 — DISPOSABLE K-PADS1976-12-16
• K761087 — ELECTRONIC CONTROL UNIT1976-12-06

Death

5

Malfunction

1,778

Total

1,783

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →