Cleared Traditional

K834148 - PHILLY BOLTS

K834148 is the FDA 510(k) clearance for PHILLY BOLTS by Philadelphia Medical Specialties. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K834148 · Philadelphia Medical Specialties · Neurology device
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Feb 1984
Decision
86d
Days
Class 2
Risk

K834148 is an FDA 510(k) clearance for the PHILLY BOLTS. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Philadelphia Medical Specialties (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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 K834148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date February 10, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 17
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K834148.
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · Bio-Logic Systems Corp. · Jul 1985
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · Teca, Inc. · Dec 1984
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · Kelleher Corp. · Aug 1982