Cleared Traditional

K854058 - PK-AC POWERED PATIENT MANUPULATING DEVICE

K854058 is an FDA 510(k) clearance for PK-AC POWERED PATIENT MANUPULATING DEVICE, manufactured by Mannesmann Demag Corp.. The device is a Class 2 General Hospital device with product code FNG cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K854058 · Mannesmann Demag Corp. · General Hospital
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Feb 1986
Decision
145d
Days
Class 2
Risk

K854058 is an FDA 510(k) clearance for the PK-AC POWERED PATIENT MANUPULATING DEVICE. Classified as Lift, Patient, Ac-powered (product code FNG), Class II - Special Controls.

Submitted by Mannesmann Demag Corp. (Solon, US). The FDA issued a Cleared decision on February 25, 1986 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5500 - 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 Mannesmann Demag Corp. devices

FDA 510(k) Submission Details - K854058

510(k) Number K854058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1985
Decision Date February 25, 1986
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNG Device Classification - Class 2, Special Controls

Product Code FNG Lift, Patient, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5500
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.