510(k) Report

FDA applicant

Rhythm Xience, Inc. (Rxi)

Eden Prairie, MN2 decisions2017–20174 recalls

FDA records 2 decisions for Rhythm Xience, Inc. (Rxi) (Eden Prairie, MN) in 2017: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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, cardiovascular panel, where it files most

How often FDA has decided Rhythm Xience, Inc. (Rxi)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

4in 2020

2020: 4
2017high 4 (2020) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Rhythm Xience, Inc. (Rxi) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rhythm Xience, Inc. (Rxi)’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?

  • DYBIntroducer, Catheter2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K171081Guider Catheter IntroducerRhythm Xience, Inc. (Rxi) · 20171cites it
  • K170373Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) · 20171cites it

What has FDA decided for it lately?

  • K171081Guider Catheter IntroducerRhythm Xience, Inc. (Rxi) · 2017
  • K170373Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) · 20174 recalls

All 2 as Rhythm Xience, Inc. (Rxi) →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K170373Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated…Feb 25, 2020Class II
  • K170373Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal…Feb 25, 2020Class II
  • K170373Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated…Feb 25, 2020Class II
  • K170373Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal…Feb 25, 2020Class II

Other applicant names beginning “Rhythm”

FDA records each applicant name separately; these may or may not be the same firm.

Rhythm AI, Ltd. 3Rhythm Al, Ltd. 1