Cleared Traditional

K862012 - LADD MEDICAL S-2000

K862012 is an FDA 510(k) clearance for LADD MEDICAL S-2000, manufactured by Ladd Research Industries, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K862012 · Ladd Research Industries, Inc. · Neurology device
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Jun 1986
Decision
12d
Days
Class 2
Risk

K862012 is an FDA 510(k) clearance for the LADD MEDICAL S-2000. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Ladd Research Industries, Inc. (Burlington, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ladd Research Industries, Inc. devices

FDA 510(k) Submission Details - K862012

510(k) Number K862012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date June 09, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 148d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 72
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K862012.
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp. · Aug 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · Camino Laboratories, Inc. · May 1988
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864 · Camino Laboratories, Inc. · Feb 1986
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984