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The Tracker / August 2026 / K254213

510(k) cleared

Pascall Sensor Unit (PSU1)

Pascall Systems, Inc. · Aug 19, 2026 · K254213

FDA cleared the Pascall Sensor Unit (PSU1) from Pascall Systems, Inc. on Aug 19, 2026 under K254213, a special 510(k). The device falls under product code OLT, Non-Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 29, 2025. The decision came 233 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Pascall Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254213?

K254213 is the FDA 510(k) for Pascall Sensor Unit (PSU1), submitted by Pascall Systems, Inc.. FDA's decision date was Aug 19, 2026, under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software).

Who makes the Pascall Sensor Unit (PSU1)?

Pascall Systems, Inc., based in Cambridge, MA, is the applicant of record for K254213.

How long did the K254213 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 19, 2026, 233 days later.

← All decisions in August 2026