Cleared Traditional

K040021 - SHUNTCHECK (PROMETHEUS 1)

K040021 is an FDA 510(k) clearance for SHUNTCHECK (PROMETHEUS 1), manufactured by Samuel Neff M.D.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K040021 · Samuel Neff M.D. · Neurology device
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Nov 2004
Decision
301d
Days
Class 2
Risk

K040021 is an FDA 510(k) clearance for the SHUNTCHECK (PROMETHEUS 1). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Samuel Neff M.D. (Haddon Heights, US). The FDA issued a Cleared decision on November 2, 2004 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Samuel Neff M.D. devices

FDA 510(k) Submission Details - K040021

510(k) Number K040021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2004
Decision Date November 02, 2004
Days to Decision 301 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 148d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 214
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MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · Medtronic Neurosurgery · Jun 2004