Cleared Traditional

MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE (K962001) - FDA 510(k) Clearance

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

K962001 · Manan Medical Products, Inc. · General Hospital
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Jan 1997
Decision
233d
Days
Class 2
Risk

K962001 is an FDA 510(k) clearance for the MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 233 days - an extended review cycle.

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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K962001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1996
Decision Date January 10, 1997
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
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 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K962001.
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K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
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