Cleared Traditional

POSEY BED (K103817) - FDA 510(k) Clearance

Class I General Hospital device.

K103817 · J. T. Posey Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
114d
Days
Class 1
Risk

K103817 is an FDA 510(k) clearance for the POSEY BED. Classified as Patient Bed With Canopy/restraints (product code OYS), Class I - General Controls.

Submitted by J. T. Posey Co. (Arcadia, US). The FDA issued a Cleared decision on April 22, 2011 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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 J. T. Posey Co. devices

Submission Details

510(k) Number K103817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date April 22, 2011
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OYS Patient Bed With Canopy/restraints
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
Definition Enclosed Bed Canopy System Used As Passive Restraint.
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.