510(k) Report

FDA applicant

Jvckenwood Corporation

Yokohama, JP22 decisions2013–20240 recalls

FDA records 22 decisions for Jvckenwood Corporation (Yokohama, JP) from 2013 to 2024: 22 510(k) clearances. Most are in product codes PGY (Display, Diagnostic Radiology) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 12 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 Jvckenwood Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 42014: 52015: 22016: 22017: 12018: 12019: 12020: 12021: 32022: 12024: 1
2013high 5 (2014) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Jvckenwood Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jvckenwood Corporation’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?

  • PGYDisplay, Diagnostic Radiology16decisions
  • LLZSystem, Image Processing, Radiological6decisions

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 64 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 58 days; 3 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 12 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.

  • K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 20194cite it
  • K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)Jvckenwood Corporation · 20164cite it
  • K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation · 20162cite it
  • K14021430.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 20141cites it
  • K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation · 20141cites it
  • K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300Jvckenwood Corporation · 20171cites it

What has FDA decided for it lately?

  • K2411053MP Color LCD Monitor (CL-S301)Jvckenwood Corporation · 2024
  • K2228648MP Color LCD Monitor CL-R813Jvckenwood Corporation · 2022
  • K2129856MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021
  • K20373312MP Color Digital Mammography LCD Monitor CL-S1200Jvckenwood Corporation · 2021
  • K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021
  • K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation · 2020
  • K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019
  • K1825392MP Color LCD Monitor CL-R211Jvckenwood Corporation · 2018

All 22 as Jvckenwood Corporation →