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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 149d · 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 258
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K040021.
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · Integra LifeSciences Corporation · Dec 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
K042481 · Sophysa SA · Dec 2004
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
K042359 · Medical Designs, LLC · Nov 2004
PS MEDICAL STRATA II VALVE
K042465 · Medtronic Neurosurgery · Oct 2004
EQUI-FLOW VALVE AND SHUNT SYSTEM
K042558 · Integra Neurosciences Implants S.A. · Oct 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198 · Medtronic Neurosurgery · Sep 2004
K040021 · SHUNTCHECK (PROMETHEUS 1)
Download PDF Samuel Neff M.D.