510(k) Report

510(k) · Cleared

Cleared

Rusch Tracheal Bronchial Y Stent

K953593510(k) TraditionalCleared Oct 13, 199574-day reviewClass II21 CFR 878.3720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rusch, Inc. · NYT Prosthesis, Tracheal, Expandable, Polymeric

Cleared on Oct 13, 1995 after a 74-day review. The FDA summary names no predicate by number.

Decided
Oct 13, 1995
Review
74 days
Class
Class II
Product code
NYT
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K953593Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All NYT devices

NYT Prosthesis, Tracheal, Expandable, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NYT

FDA has decided no NYT device since 2007.

Median 510(k) review, days · NYT

Too few NYT 510(k)s in any year since 2007 to give a median.

Recalls per year · NYT

No recall names NYT since 2007.

Adverse event reports per year · NYT

1in 2024

2007: 122008: 32009: 132010: 62011: 32012: 62013: 12014: 22015: 22016: 22017: 32019: 12024: 1
2007high 13 (2009) · low 0 (2018)2025

MAUDE reports naming product code NYT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—012
20080—03
20090—013
20100—06
20110—03
20120—06
20130—01
20140—02
20150—02
20160—02
20170—03
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Rusch, Inc.

26 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in NYT

The NYT category page

  • K013266Rusch Polyflex Stent KitRusch Intl. · 2001
  • K982614Rusch Polyflex Stent KitRusch Intl. · 1998

https://510kreport.com/device/K953593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953593: Rusch Tracheal Bronchial Y Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953593

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026