Brainspec, Inc.

FDA Regulatory Profile

Brainspec, Inc. appears in FDA public data with 0 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Jun 24, 2026 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Nov 14, 2023.

Reviewing Brainspec, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Brainspec, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Total Recalls
0
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 24, 2026Framingham, MADevicesVoluntary Action Indicated (VAI)3035371452

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K230856BrainSpec Core™ SoftwareNov 14, 2023