Cleared Traditional

PHILLY BOLT (K813440) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813440 · Philadelphia Medical Specialties · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
10d
Days
Class 2
Risk

K813440 is an FDA 510(k) clearance for the PHILLY 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 December 18, 1981 after a review of 10 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 K813440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1981
Decision Date December 18, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 148d · This submission: 10d
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 21
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K813440.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063 · Cordis Corp. · Jan 1978