510(k) Report

FDA applicant

Plaxtron Industrial (M) Sdn. Bhd.

Kaohsiung City, TW1 decision2012–20123 recalls

FDA records 1 decision for Plaxtron Industrial (M) Sdn. Bhd. (Kaohsiung City, TW) in 2012: 1 510(k) clearance. All are in product code JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are 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 Plaxtron Industrial (M) Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2026

2017: 12020: 12026 (partial year): 1
2012high 1 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Plaxtron Industrial (M) Sdn. Bhd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Plaxtron Industrial (M) Sdn. Bhd.’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?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K120065Plaxtron Suction Unit, Model 88AA51/88AA61 SeriesPlaxtron Industrial (M) Sdn. Bhd. · 20121cites it

What has FDA decided for it lately?

  • K120065Plaxtron Suction Unit, Model 88AA51/88AA61 SeriesPlaxtron Industrial (M) Sdn. Bhd. · 20123 recalls

The one decision as Plaxtron Industrial (M) Sdn. Bhd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K120065Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA…Jan 13, 2026Class II
  • K120065Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052…Dec 18, 2020Class II
  • K120065LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered…Aug 31, 2017Class II