Cleared Special

K254213 - Pascall Sensor Unit (PSU1)

K254213 is an FDA 510(k) clearance for Pascall Sensor Unit (PSU1), manufactured by Pascall Systems, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Special 510(k) pathway after a 233-day FDA review.

K254213 · Pascall Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
233d
Days
Class 2
Risk

K254213 is an FDA 510(k) clearance for the Pascall Sensor Unit (PSU1). Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Pascall Systems, Inc. (Cambridge, US). The FDA issued a Cleared decision on August 19, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pascall Systems, Inc. devices

FDA 510(k) Submission Details - K254213

510(k) Number K254213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date August 19, 2026
Days to Decision 233 days
Submission Type Special
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
85d slower than avg
Panel avg: 148d · This submission: 233d
Pathway characteristics
Modification to existing cleared device.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 Consultant

Steurer Consulting Group
Robert Steurer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 30
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K254213.
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