510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Rusch Endobronchial Tube Sets

K951091510(k) TraditionalCleared Jun 8, 199591-day reviewClass II21 CFR 868.5720Recalls 10

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

Rusch Intl. · BTS Tube, Bronchial (W/Wo Connector)

Cleared on Jun 8, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 10 times.

Decided
Jun 8, 1995
Review
91 days
Class
Class II
Product code
BTS
Recalls
10
Predicates
0

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

FIG. 1 — Lineage of K951091Source: FDA 510(k) database · How lineage is built

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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 BTS? 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
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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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2014Class IIZ-2407-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2411-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2413-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2415-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2414-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2410-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2408-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2412-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Nov 21, 2014Class IIZ-2409-2015OtherCustomer complaints reporting that the cobb connector detached from the main connector prior to use.
Feb 28, 2014Class IIZ-1231-2014Device DesignThe product may fail to achieve seal of right lung due to the cuff inflating to one side

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All BTS devices

BTS Tube, Bronchial (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTS

FDA has decided no BTS device since 2007.

Median 510(k) review, days · BTS

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

Recalls per year · BTS

No recall names BTS since 2007.

Adverse event reports per year · BTS

204in 2025

2007: 12009: 22010: 242011: 292012: 892013: 1162014: 2282015: 3122016: 2262017: 1902018: 1242019: 1222020: 912021: 1102022: 1402023: 1622024: 1722025: 204
2007high 312 (2015) · low 0 (2008)2025

MAUDE reports naming product code BTS, 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—01
20080—00
20090—02
20100—024
20110—029
20120—089
20130—0116
20140—0228
20150—0312
20160—0226
20170—0190
20180—0124
20190—0122
20200—091
20210—0110
20220—0140
20230—0162
20240—0172
20250—0204
20260—0—

More from Rusch Intl.

43 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in BTS

The BTS category page

  • K953963Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial IntubationRusch, Inc. · 1995
  • K902116Modified Endobronchial TubeConcord/Portex · 1990
  • K834565Endobronchial Twin Lumen TubePortex, Inc. · 1984
  • K833297Bronchoscopy Tube W/Ultra LocuffSurgitek · 1983
  • K771219Broncho-CathMallinckrodt Critical Care · 1977

https://510kreport.com/device/K951091 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951091: Rusch Endobronchial Tube Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951091

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026