510(k) Report

FDA applicant

Bioinfinity (M) Sdn. Bhd.

Kepong, MY2 decisions2014–20170 recalls

FDA records 2 decisions for Bioinfinity (M) Sdn. Bhd. (Kepong, MY) from 2014 to 2017: 2 510(k) clearances. All are in product code HIR (Perineometer). Its devices cite 2 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Bioinfinity (M) Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014: 12017: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bioinfinity (M) Sdn. Bhd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HIRPerineometer2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 20171cites it
  • K141893Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 20141cites it

What has FDA decided for it lately?

  • K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017
  • K141893Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014

All 2 as Bioinfinity (M) Sdn. Bhd. →