510(k) Report

510(k) · Cleared

Cleared

Rusch Single Use Crystal Tracheostomy Tube Set

K972546510(k) TraditionalCleared Apr 14, 1998280-day reviewClass II21 CFR 868.5800

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

Rusch Intl. · JOH Tube Tracheostomy And Tube Cuff

Cleared on Apr 14, 1998 as substantially equivalent to K934465 (Smiths Industries Medical Systems, Inc., 1994) and 2 other predicates after a 280-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.

Decided
Apr 14, 1998
Review
280 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K913270 (1991). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1991: 1 other ancestor2003: 1 descendant cleared2014: 1 descendant clearedK913270 · Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube · Bivona Medical Technologies · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K913270 · Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube · Bivona Medical Technologies · 19910
  1. Root · 1 generation backK913270 Bivona Fome-Cuf (R) Pediatric Tracheostomy TubeBivona Medical Technologies · 1991
  2. This deviceK972546 Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998
  3. Descendant · cites it directly · 1 of its ownK023918 Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 2003 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK133173 Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 2003 · cites it directly1descendant
  • K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913270Bivona Fome-Cuf (R) Pediatric Tracheostomy TubeBivona Medical Technologies1991—
0 (this device)K972546Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl.1998—
+1K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl.20032
+2K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201410
FIG. 1 — Lineage of K972546, 1991–2014Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 JOH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOH device

  1. #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K934465Dic Tracheostomy Tube and Portex Blue Line
Summary page 1
…device 3. Comparison Devices Risch (Warne Surgical Products) Crystal Tracheostomy Tube - Preamendment Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465 Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088 4. Description of Device Set…
Smiths Industries Medical Systems, Inc.19942
*K913270Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube
Summary page 1
…heostomy Tube - Preamendment Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465 Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088 4. Description of Device Set The Riisch Single Use Crystal Tracheostomy Tube set consists of a polyviny…
Bivona Medical Technologies1991—
*K914088Bivona Aire-Cuf (R) Pediatric Tracheostomy Tube
Summary page 1
…Tube - Preamendment Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465 Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088 4. Description of Device Set The Riisch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chlorid…
Bivona Medical Technologies19913
*—Risch (Warne Surgical Products) Crystal Tracheostomy Tube - Preamendment
Named without a submission number
—

Also cleared against K934465: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl.20031

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?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K023918 (Rusch Intl., 2003) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K934465.

How does its category compare?

All JOH devices

JOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOH

1in 2025

2007: 12008: 22009: 12010: 22012: 12013: 32014: 32015: 32016: 12017: 12018: 32019: 22020: 12021: 22025: 1
2007high 3 (2013) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOH

137in 2018

2013: 407 days median2014: 218 days median2015: 179 days median2018: 137 days median
2007high 407 (2013) · low 137 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOH

1in 2023

2007: 12009: 12010: 732011: 42016: 2, 1 Class I2020: 12023: 12026 (partial year): 1
2007high 73 (2010) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · JOH

986in 2025

2007: 1672008: 1022009: 1952010: 1,2702011: 5872012: 5002013: 5442014: 5062015: 5082016: 5722017: 4412018: 8122019: 1,0192020: 7912021: 1,0412022: 1,6322023: 1,2332024: 1,1032025: 986
2007high 1,632 (2022) · low 102 (2008)2025

MAUDE reports naming product code JOH, 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
20071—1167
20082—0102
20091—1195
20102—731,270
20110—4587
20121—0500
201334070544
201432180506
201531790508
20161—2 (1)572
20171—0441
201831370812
20192—01,019
20201—1791
20212—01,041
20220—01,632
20230—11,233
20240—01,103
20251—0986
20260—1—

What is it indicated for?

The Riasch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K934465

3 other devices cite the same predicate.

  • K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 20037 recalls
  • K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. · 19971 Class I recall
  • K955564Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996

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 JOH

The JOH category page

  • K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula…Covidien, LLC · 2025
  • K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra…Smiths Medical Asd, Inc. · 2021
  • K203362TRACOE varioTracoe Medical GmbH · 2021
  • K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
  • K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 20192 Class I recalls

https://510kreport.com/device/K972546 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972546: Rusch Single Use Crystal Tracheostomy Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972546

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