Cleared Traditional

PK-AC POWERED PATIENT MANUPULATING DEVICE (K854058) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854058 · Mannesmann Demag Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.