FDA applicant
Chase Medical, Inc.
FDA records 29 decisions for Chase Medical, Inc. (Richardson, TX) from 1997 to 2007: 29 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 16 predicates, 0 of them its own earlier devices. 15 recalls are linked to its devices.
FDA’s records also spell it “Chase Medical, LP”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Chase Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Chase Medical, 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 “Chase”
FDA records each applicant name separately; these may or may not be the same firm.