Cleared Traditional

UROSURGE UROTHERM FLUID WARMING SYSTEM (K965136) - FDA 510(k) Clearance

Class I General Hospital device.

K965136 · Princeton Regulatory Assoc. · General Hospital
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Oct 1998
Decision
662d
Days
Class 1
Risk

K965136 is an FDA 510(k) clearance for the UROSURGE UROTHERM FLUID WARMING SYSTEM. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 662 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5950 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Princeton Regulatory Assoc. devices

Submission Details

510(k) Number K965136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date October 16, 1998
Days to Decision 662 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
533d slower than avg
Panel avg: 129d · This submission: 662d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHC Warmer, Irrigation Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.