Cleared Traditional

ULTRAFIT LINERS (K954314) - FDA 510(k) Clearance

Class I General Hospital device.

K954314 · Stahmer Weston Scientific · General Hospital
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Dec 1995
Decision
104d
Days
Class 1
Risk

K954314 is an FDA 510(k) clearance for the ULTRAFIT LINERS. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Stahmer Weston Scientific (Portsmouth, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Stahmer Weston Scientific devices

Submission Details

510(k) Number K954314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date December 28, 1995
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.