Pascall Sensor Unit (PSU1)— 510(k) K254213

Name: FDA 510(k) clearance K254213
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Substantially Equivalent

Pascall Systems, Inc.

FDA 510(k) clearance K254213 for Pascall Sensor Unit (PSU1), Substantially Equivalent on 2026-08-19. Applicant: Pascall Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pascall Systems, Inc.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-12-29
Decision date: 2026-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLT

view all

K253767 — UB ERP System2026-06-30
K251881 — HippoMind (v1.0)2025-12-03
K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2025-10-09
K240593 — VEEGix EEG System2024-08-23
K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software2022-11-30

More clearances from Pascall Systems, Inc.

view all

K213299 — Wireless EEG System2022-05-11

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.