Cleared Traditional

K113355 - POSEY BED

K113355 is an FDA 510(k) clearance for POSEY BED, manufactured by J. T. Posey Co.. The device is a Class 1 General Hospital device with product code OYS cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K113355 · J. T. Posey Co. · General Hospital
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May 2012
Decision
170d
Days
Class 1
Risk

K113355 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 May 2, 2012 after a review of 170 days - an extended review cycle.

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

FDA 510(k) Submission Details - K113355

510(k) Number K113355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date May 02, 2012
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

OYS Device Classification - Class 1, General Controls

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.