Koya Medical, Inc.

FDA Regulatory Profile

Koya Medical, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Oct 24, 2025 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Jan 4, 2024.

Reviewing Koya Medical, 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 Koya Medical, 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
3
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 24, 2025Dallas, TXDevicesVoluntary Action Indicated (VAI)3033981998

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

Recent 510(k) Clearances

K-NumberDeviceDate
K223228DayspringJan 4, 2024
K212287Dayspring LiteSep 21, 2021
K210885DayspringApr 23, 2021