Cleared Traditional

SLOAN STA-DRI SURGICAL JUMPSUIT (K944118) - FDA 510(k) Clearance

Class I General Hospital device.

K944118 · Sloan Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.