Cleared Traditional

K925924 - NEAL WRIST CONES

K925924 is an FDA 510(k) clearance for NEAL WRIST CONES, manufactured by Neal & Assoc., Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K925924 · Neal & Assoc., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
136d
Days
Class 1
Risk

K925924 is an FDA 510(k) clearance for the NEAL WRIST CONES. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Neal & Assoc., Inc. (Columbia, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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 Neal & Assoc., Inc. devices

FDA 510(k) Submission Details - K925924

510(k) Number K925924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date April 08, 1993
Days to Decision 136 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
7d slower than avg
Panel avg: 129d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 123
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K925924.
PATIENT PROTECTIVE LIMB
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HEAD PROTECTOR
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