Cleared Traditional

K060986 - HEAD BED

K060986 is an FDA 510(k) clearance for HEAD BED, manufactured by Steven H. Warnock, M.D.. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K060986 · Steven H. Warnock, M.D. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
92d
Days
Class 1
Risk

K060986 is an FDA 510(k) clearance for the HEAD BED. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Steven H. Warnock, M.D. (Sandy, US). The FDA issued a Cleared decision on July 11, 2006 after a review of 92 days - within the typical 510(k) review window.

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 - K060986

510(k) Number K060986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date July 11, 2006
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 K060986.
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NIGHTFORM
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K003511 · The Ludlow Company LP · Jan 2001
K060986 · HEAD BED
Download PDF FDA Summary Steven H. Warnock, M.…