510(k) Report

FDA applicant

Carilex Medical, Inc.

Taoyuan City, TW4 decisions2016–20240 recalls

FDA records 4 decisions for Carilex Medical, Inc. (Taoyuan City, TW) from 2016 to 2024: 4 510(k) clearances. All are in product code OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 276 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2024

2016: 12018: 22024: 1
2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Carilex Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carilex 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) Report

Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 276 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 198 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173407VT - 100, VT - 200Carilex Medical, Inc. · 20181cites it
  • K172725VT Dressing KitsCarilex Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K231646Carilex VT¿200-i NXCarilex Medical, Inc. · 2024
  • K173407VT - 100, VT - 200Carilex Medical, Inc. · 2018
  • K172725VT Dressing KitsCarilex Medical, Inc. · 2018
  • K161410VT·One, VT·One 60daysCarilex Medical, Inc. · 2016

All 4 as Carilex Medical, Inc. →