RK2000 K-THERMIA SYSTEM— 510(k) K882442

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K882442 for RK2000 K-THERMIA SYSTEM, Substantially Equivalent on 1988-09-06. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1988-06-14
Decision date: 1988-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.