Data / Medical devices / United States / Pascall Systems Inc

Pascall Systems Inc: FDA-registered device maker in Cambridge, MA, United States, 2 510(k) clearances

Name: Pascall Systems Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pascall Systems Inc is registered with the FDA (registration 3024892936) in Cambridge, MA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 19, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3024892936
Address: 625 Mass Ave, Cambridge, MA, United States, 02139
Owner or operator: Pascall Systems Inc (10086400)
Roles: Complaint file establishment, Manufacturer
First device listed: November 7, 2022
Registered through: 2027
Brand names listed: Pascall Sensor Unit PSU1, Wireless EEG System

Devices it lists

Device	Product code	Class	Role	Source
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 19, 2026	K254213	Pascall Sensor Unit (PSU1)	OLT	Substantially Equivalent	Pascall Systems, Inc.	accessdata.fda.gov
May 11, 2022	K213299	Wireless EEG System	OLT	Substantially Equivalent	Pascall Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.