Cleared Traditional

K952303 - SPLASH ASSIST

K952303 is an FDA 510(k) clearance for SPLASH ASSIST, manufactured by Innovative Outsourcing Solutions. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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.

FDA 510(k) Submission Details - K952303

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 55
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K952303.
SLOAN STA-DRI PANT PROTECTOR
K945302 · Sloan Corp. · Mar 1996
ULTRAFIT LINERS
K954314 · Stahmer Weston Scientific · Dec 1995
I-SPOUSE
K953089 · Products For Medicine · Oct 1995
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200 · Thantex Specialties, Inc. · Aug 1995
SLOAN STA-DRI SURGICAL JUMPSUIT
K944118 · Sloan Corp. · Jul 1995
SLOAN STA-DRI BOOTLEG LEGGING
K944276 · Sloan Corp. · Jul 1995
K952303 · SPLASH ASSIST
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