Cleared Traditional

SPLASH ASSIST (K952303) - FDA 510(k) Clearance

Class I General Hospital device.

K952303 · Innovative Outsourcing Solutions · General Hospital
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Aug 1995
Decision
100d
Days
Class 1
Risk

K952303 is an FDA 510(k) clearance for the SPLASH ASSIST. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Innovative Outsourcing Solutions (N. Chelmsford, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 100 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 Innovative Outsourcing Solutions devices

Submission Details

510(k) Number K952303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date August 24, 1995
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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.