510(k) Report

FDA applicant

Leltek, Inc.

New Taipei City, TW5 decisions2020–20250 recalls

FDA records 5 decisions for Leltek, Inc. (New Taipei City, TW) from 2020 to 2025: 5 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2025

2020: 12021: 12022: 12024: 12025: 1
2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Leltek, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leltek, 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 212 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 20223cite it
  • K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C)…Leltek, Inc. · 20242cite it
  • K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 20211cites it
  • K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System…Leltek, Inc. · 20251cites it
  • K191235Leltek Ultrasound Imaging SystemLeltek, Inc. · 20201cites it

What has FDA decided for it lately?

  • K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System…Leltek, Inc. · 2025
  • K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C)…Leltek, Inc. · 2024
  • K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2022
  • K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2021
  • K191235Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020

All 5 as Leltek, Inc. →