Cleared Traditional

K051300 - ROBIN HOOD VEST

K051300 is an FDA 510(k) clearance for ROBIN HOOD VEST, manufactured by Kamber Corporation. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K051300 · Kamber Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
204d
Days
Class 1
Risk

K051300 is an FDA 510(k) clearance for the ROBIN HOOD VEST. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Kamber Corporation (Washington, US). The FDA issued a Cleared decision on December 8, 2005 after a review of 204 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5680 - 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.

FDA 510(k) Submission Details - K051300

510(k) Number K051300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date December 08, 2005
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

FRP Device Classification - Class 1, General Controls

Product Code FRP Holder, Infant Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
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.

Regulatory Peers - FRP Holder, Infant Position

All 13
Devices cleared under the same product code (FRP) and FDA review panel - the closest regulatory comparables to K051300.
RES-Q INFANT WEDGE AND SLING
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HEAD BED
K060986 · Steven H. Warnock, M.D. · Jul 2006
NIGHTFORM
K041996 · Plastic Surgery Solutions, LLC · Aug 2004
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K003511 · The Ludlow Company LP · Jan 2001
NEONATAL RESTRAINT AND COMFORT SYSTEMS
K943017 · K.Bowmed, Inc. · Jan 1995
K051300 · ROBIN HOOD VEST
Download PDF FDA Summary Kamber Corporation