Cleared Traditional

K944118 - SLOAN STA-DRI SURGICAL JUMPSUIT

K944118 is an FDA 510(k) clearance for SLOAN STA-DRI SURGICAL JUMPSUIT, manufactured by Sloan Corp.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K944118 · Sloan Corp. · General Hospital
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Jul 1995
Decision
342d
Days
Class 1
Risk

K944118 is an FDA 510(k) clearance for the SLOAN STA-DRI SURGICAL JUMPSUIT. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Sloan Corp. (Omaha, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sloan Corp. devices

FDA 510(k) Submission Details - K944118

510(k) Number K944118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1994
Decision Date July 31, 1995
Days to Decision 342 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
213d slower than avg
Panel avg: 129d · This submission: 342d
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 16
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K944118.
AMMI MAGNI-GUARD
K961454 · American Medical Mfg., Inc. · Jul 1996
SLOAN STA-DRI PANT PROTECTOR
K945302 · Sloan Corp. · Mar 1996
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200 · Thantex Specialties, Inc. · Aug 1995
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
TECNOL SPLASHGUARD
K934842 · Tecnol Medical Products, Inc. · Mar 1994