FDA applicant
Pathway Medical Technologies, Inc.
FDA records 16 decisions for Pathway Medical Technologies, Inc. (Kirkland, WA) from 2008 to 2012: 16 510(k) clearances. All are in product code MCW (Catheter, Peripheral, Atherectomy). Its devices cite 72 predicates, 60 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pathway Medical Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Pathway Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Pathway”
FDA records each applicant name separately; these may or may not be the same firm.