Cleared Traditional

K840999 - PHILLY INFANT BOLT

K840999 is the FDA 510(k) clearance for PHILLY INFANT BOLT by Philadelphia Medical Specialties. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K840999 · Philadelphia Medical Specialties · Neurology device
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Apr 1984
Decision
26d
Days
Class 2
Risk

K840999 is an FDA 510(k) clearance for the PHILLY INFANT BOLT. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Philadelphia Medical Specialties (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 26 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 Philadelphia Medical Specialties devices

Submission Details

510(k) Number K840999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date April 04, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K840999.
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864 · Medex, Inc. · Nov 1982
CHEEK EPIDURAL SCREW
K802137 · Codman & Shurtleff, Inc. · Oct 1980