510(k) Report

FDA product code · General and plastic surgery

Prosthesis, Tracheal, Expandable, Polymeric

NYTClass II21 CFR 878.3720510(k) required3 decisions since 19950 recalls

3 FDA decisions since 1995. No recall names this code. The most-cited predicate is K013266, named by 4 later devices.

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

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

FIG. A — Illustration, general and plastic surgery panel

Twenty years of NYT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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

Planning a device in NYT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NYT devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K013266Rusch Polyflex Stent KitRusch Intl. · 20014cite it

What has FDA decided in NYT lately?

  • K013266Rusch Polyflex Stent KitRusch Intl. · 2001
  • K982614Rusch Polyflex Stent KitRusch Intl. · 1998
  • K953593Rusch Tracheal Bronchial Y StentRusch, Inc. · 1995

All 3 NYT decisions →

Related product codes

Other codes under 21 CFR 878.3720.

NWA Prosthesis, Tracheal, Preformed/MoldedJCT Prosthesis, Tracheal, Expandable