Cleared Traditional

K951300 - NEZHAT-DORSEY THERMAL RETENTION SYSTEM

K951300 is an FDA 510(k) clearance for NEZHAT-DORSEY THERMAL RETENTION SYSTEM, manufactured by American Hydro-Surgical Instruments, Inc.. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K951300 · American Hydro-Surgical Instruments, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
90d
Days
Class 1
Risk

K951300 is an FDA 510(k) clearance for the NEZHAT-DORSEY THERMAL RETENTION SYSTEM. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by American Hydro-Surgical Instruments, Inc. (Delray Beach, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 90 days - within the typical 510(k) review window.

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: 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 American Hydro-Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K951300

510(k) Number K951300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1995
Decision Date June 20, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LHC Device Classification - Class 1, General Controls

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.

Regulatory Peers - LHC Warmer, Irrigation Solution

Devices cleared under the same product code (LHC) and FDA review panel - the closest regulatory comparables to K951300.
WARMETTE
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