FDA 510(k) clearance · back to tracker

Pascall Sensor Unit (PSU1)

Pascall Systems, Inc. cleared K254213 on 2026-08-19, decision: substantially equivalent

K-number

K254213

Sponsor

Pascall Systems, Inc.

Device

Pascall Sensor Unit (PSU1)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-19

Product code

OLT

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.1400

Official FDA record

Open K254213on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.