Cleared Traditional

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

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073363 · Paladin Biomedical Corporation · General Hospital
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Mar 2008
Decision
111d
Days
Class 2
Risk

K073363 is an FDA 510(k) clearance for the THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Paladin Biomedical Corporation (Weston, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Paladin Biomedical Corporation devices

Submission Details

510(k) Number K073363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date March 20, 2008
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K073363.
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