510(k) Report

FDA applicant

Chase Medical, Inc.

Richardson, TX29 decisions1997–200715 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Chase Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007: 132018: 12024: 1
2007high 13 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Chase Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Chase”

FDA records each applicant name separately; these may or may not be the same firm.