510(k) Report

FDA applicant

Curative Medical, Inc.

Fulshear, TX6 decisions2012–20150 recalls

FDA records 6 decisions for Curative Medical, Inc. (Fulshear, TX) from 2012 to 2015: 6 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 3 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, last Nov 3, 2026

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

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

FDA decisions per year

1in 2015

2012: 12013: 32014: 12015: 1
2012high 3 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Curative Medical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Curative”

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