Cleared Traditional

POSEY BED (K113357) - FDA 510(k) Clearance

Class I General Hospital device.

K113357 · J. T. Posey Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
128d
Days
Class 1
Risk

K113357 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 March 21, 2012 after a review of 128 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 K113357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date March 21, 2012
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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.