510(k) Report

510(k) · Cleared

Cleared

Rusch Endotracheal Tube Stylet

K952100510(k) TraditionalCleared Aug 8, 199596-day reviewClass I21 CFR 868.5790

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

Rusch, Inc. · BSR Stylet, Tracheal Tube

Cleared on Aug 8, 1995 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 8, 1995
Review
96 days
Class
Class I
Product code
BSR
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952100 Rusch Endotracheal Tube StyletRusch, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK080339 Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080339Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952100Rusch Endotracheal Tube StyletRusch, Inc.1995—
+1K080339Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K952100, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BSR? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080339Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC20080

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.

What does this lineage say?

  • Of its descendants, K080339 (Medsource International, LLC, 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BSR devices

BSR Stylet, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSR

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSR

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

Recalls per year · BSR

3in 2024

2008: 32011: 12014: 12015: 22016: 12024: 3
2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BSR

18in 2025

2007: 162008: 92009: 72010: 182011: 182012: 272013: 352014: 552015: 222016: 92017: 122018: 152019: 182020: 52021: 112022: 52023: 192024: 312025: 18
2007high 55 (2014) · low 5 (2020)2025

MAUDE reports naming product code BSR, 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—016
20080—39
20090—07
20100—018
20110—118
20120—027
20130—035
20140—155
20150—222
20160—19
20171—012
20180—015
20190—018
20200—05
20210—011
20220—05
20230—019
20240—331
20250—018
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 BSR

The BSR category page

  • K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook…Cook Incorporated · 2017
  • K962361Trachlight Stylet and Tracheal LightwandLaerdal Medical Corp. · 1996
  • K954771Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand)Laerdal Medical Corp. · 1996
  • K943104Molloy Intubating StyletteMolloy Corp. · 1996
  • K955238Rusch Schroeder Endotracheal Tube StyleRusch Intl. · 1996

https://510kreport.com/device/K952100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952100: Rusch Endotracheal Tube Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952100

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026