Cleared Traditional

SAFETY CRADLE (K962149) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962149 · Specialized Health Products, Inc. · General Hospital
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Oct 1996
Decision
129d
Days
Class 2
Risk

K962149 is an FDA 510(k) clearance for the SAFETY CRADLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Specialized Health Products, Inc. (Sandy, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Specialized Health Products, Inc. devices

Submission Details

510(k) Number K962149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date October 11, 1996
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 182
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K962149.
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LIFESHIELD BLUNT CANNULA
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MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
K960982 · Sherwood Medical Co. · Dec 1996
GE STERILE ARTHROGRAM TRAY
K962035 · GE Medical Systems · Jun 1996
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1996
SAFETYGLIDE NEEDLE
K951254 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995