510(k) Report

FDA applicant

R&R Medical Corporation, Ltd.

New Taipei City, TW4 decisions2005–20230 recalls

FDA records 4 decisions for R&R Medical Corporation, Ltd. (New Taipei City, TW) from 2005 to 2023: 4 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and FXX (Mask, Surgical). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “R&R Medical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided R&R Medical Corporation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R&R Medical Corporation, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R&R Medical Corporation, Ltd.’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?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions
  • FXXMask, Surgical1decision
  • NUCLubricant, Personal1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K052005R&R External Fixation SystemR&R Medical, Inc. · 20056cite it
  • K043174Stealth Fusion System, Model RR 1000R&R Medical, Inc. · 20052cite it

What has FDA decided for it lately?

  • K220226X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023
  • K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd. · 2022
  • K052005R&R External Fixation SystemR&R Medical, Inc. · 2005
  • K043174Stealth Fusion System, Model RR 1000R&R Medical, Inc. · 2005

All 2 as R&R Medical Corporation, Ltd. →All 2 as R&R Medical, Inc. →