510(k) Report

FDA applicant

Rusch, Inc.

Jeffrey, NH26 decisions1993–200148 recalls

FDA records 26 decisions for Rusch, Inc. (Jeffrey, NH) from 1993 to 2001: 26 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and EZL (Catheter, Retention Type, Balloon). Its devices cite 6 predicates, 0 of them its own earlier devices. 48 recalls are linked to its devices, 38 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rusch, Inc. since 2007.

Recalls per year

38in 2023

2014: 12016: 12019: 52020: 12022: 12023: 38, 38 Class I
2007high 38 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Rusch, Inc. 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)10decisions
  • EZLCatheter, Retention Type, Balloon2decisions
  • FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2decisions
  • KOBCatheter, Suprapubic (And Accessories)2decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • CBPValve, Non-Rebreathing1decision

Also: FPD (1), JOH (1), BTS (1), BSR (1), NYT (1), BTM (1).

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 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.

  • K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 19934cite it
  • K931166Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYRusch, Inc. · 19933cite it
  • K010420Rusch MMG/O'neil CatheterRusch, Inc. · 20013cite it
  • K980870Rusch Silicone Foley CatheterRusch, Inc. · 19982cite it
  • K963993Rusch Simplastic Foley Catheterization SetRusch, Inc. · 19962cite it
  • K970021Rusch Suprapubic TrayRusch, Inc. · 19972cite it

What has FDA decided for it lately?

  • K010420Rusch MMG/O'neil CatheterRusch, Inc. · 20013 recalls
  • K993528Rusch Emergency MaskRusch, Inc. · 2000
  • K993194Rusch Manual Resuscitator BagRusch, Inc. · 2000
  • K980870Rusch Silicone Foley CatheterRusch, Inc. · 1998
  • K974419Rusch Simplastic Councill Tip CatheterRusch, Inc. · 1998
  • K963779Rusch Enteral Feeding TubeRusch, Inc. · 1997
  • K970021Rusch Suprapubic TrayRusch, Inc. · 1997
  • K963993Rusch Simplastic Foley Catheterization SetRusch, Inc. · 1996

All 26 as Rusch, Inc. →

What has been recalled?

48 recalls linked to its devices; the latest:

  • K931163Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF…May 25, 2023Class I
  • K931163Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF…May 25, 2023Class I
  • K931166Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060May 25, 2023Class I
  • K931163Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF…May 25, 2023Class I
  • K931164Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF…May 25, 2023Class I
  • K931164Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF…May 25, 2023Class I

Other applicant names beginning “Rusch”

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

Rusch Intl. 43