510(k) Report

FDA applicant

Rusch Intl.

Jeffrey, NH43 decisions1995–200390 recalls

FDA records 43 decisions for Rusch Intl. (Jeffrey, NH) from 1995 to 2003: 43 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 32 predicates, 7 of them its own earlier devices. 90 recalls are linked to its devices, 60 Class I.

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

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

How often FDA has decided Rusch Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rusch Intl. since 2007.

Recalls per year

59in 2023

2011: 22014: 132016: 1, 1 Class I2018: 12019: 12021: 32022: 12023: 59, 59 Class I
2007high 59 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • BTRTube, Tracheal (W/Wo Connector)7decisions
  • JOHTube Tracheostomy And Tube Cuff5decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • EZLCatheter, Retention Type, Balloon4decisions
  • KODCatheter, Urological2decisions
  • NYTProsthesis, Tracheal, Expandable, Polymeric2decisions

Also: ESW (2), FEN (2), CAE (1), FAP (1), CAZ (1), BSP (1).

Whose devices does it build on?

Its devices cite 32 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 48 times; 7 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.

  • K000070FlocathRusch Intl. · 20006cite it
  • K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 20006cite it
  • K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 19965cite it
  • K013266Rusch Polyflex Stent KitRusch Intl. · 20014cite it
  • K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl. · 20034cite it
  • K951046Rusch Endotest Cuff Pressure MonitorRusch Intl. · 19953cite it

What has FDA decided for it lately?

  • K033023Intermittent Urethral CathetersRusch Intl. · 2003
  • K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl. · 2003
  • K023666Rusch Guided Cholangiography CatheterRusch Intl. · 2003
  • K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 20032 recalls
  • K023964Rusch Microlaryngeal TubeRusch Intl. · 2002
  • K021540Rusch Edgar TubeRusch Intl. · 2002
  • K021764Rusch Tracheofix Set, Cuffed and UncuffedRusch Intl. · 2002
  • K020714Rusch Floneil; Flocath IntrogelRusch Intl. · 2002

All 43 as Rusch Intl. →

What has been recalled?

90 recalls linked to its devices; the latest:

  • K961837Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095May 25, 2023Class I
  • K961840Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540May 25, 2023Class I
  • K961840Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525May 25, 2023Class I
  • K993786RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025May 25, 2023Class I
  • K961840Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065May 25, 2023Class I
  • K961837Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585May 25, 2023Class I

Other applicant names beginning “Rusch”

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

Rusch, Inc. 26