510(k) Report

FDA applicant

Choong Wae Medical Corp.

Marietta, GA2 decisions2004–20090 recalls

FDA records 2 decisions for Choong Wae Medical Corp. (Marietta, GA) from 2004 to 2009: 2 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and KPR (System, X-Ray, Stationary). Its devices cite 3 predicates, 0 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 hospital panel, where it files most

How often FDA has decided Choong Wae Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Choong Wae Medical Corp.’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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Which product codes does it file in?

  • FMZIncubator, Neonatal1decision
  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp. · 20092cite it

What has FDA decided for it lately?

  • K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp. · 2009
  • K040910Infant Incubator, Model CHS-I1000Choong Wae Medical Corp. · 2004

All 2 as Choong Wae Medical Corp. →