Cleared Traditional

K962288 - COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER

K962288 is an FDA 510(k) clearance for COVER-ALL, manufactured by Pinnacle Products, Inc.. The device is a Class 2 General Hospital device with product code MMP cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K962288 · Pinnacle Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
230d
Days
Class 2
Risk

K962288 is an FDA 510(k) clearance for the COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER. Classified as Cover, Barrier, Protective (product code MMP), Class II - Special Controls.

Submitted by Pinnacle Products, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Pinnacle Products, Inc. devices

FDA 510(k) Submission Details - K962288

510(k) Number K962288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date January 30, 1997
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMP Device Classification - Class 2, Special Controls

Product Code MMP Cover, Barrier, Protective
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.