Cleared Traditional

K221694 - External Drainage System

K221694 is an FDA 510(k) clearance for External Drainage System, manufactured by Jmed(Shenzhen) Technology Limited. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K221694 · Jmed(Shenzhen) Technology Limited · Neurology device
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Feb 2023
Decision
244d
Days
Class 2
Risk

K221694 is an FDA 510(k) clearance for the External Drainage System. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Jmed(Shenzhen) Technology Limited (Shenzhen City, CN). The FDA issued a Cleared decision on February 9, 2023 after a review of 244 days - an extended review cycle.

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. Standard predicate reliance. 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 Jmed(Shenzhen) Technology Limited devices

FDA 510(k) Submission Details - K221694

510(k) Number K221694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2022
Decision Date February 09, 2023
Days to Decision 244 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 148d · This submission: 244d
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 177
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