THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300— 510(k) K073363

Name: FDA 510(k) clearance K073363
Creator: U.S. Food and Drug Administration
Published: 2008-03-20

Substantially Equivalent

Paladin Biomedical Corporation

FDA 510(k) clearance K073363 for THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300, Substantially Equivalent on 2008-03-20. Applicant: Paladin Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Paladin Biomedical Corporation
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-11-30
Decision date: 2008-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGZ

view all

K260988 — °M Warmer System with °M Station2026-04-24
K252636 — Fluido Compact System2025-11-18
K251733 — Fluido® AirGuard System2025-09-04
K232107 — °M Warmer System2024-05-31
K211618 — Fluido Compact Blood and Fluid Warming System2023-06-05

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.