510(k) · Cleared
Recalled · Class I · 2026Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · JOH Tube Tracheostomy And Tube Cuff
Cleared on Dec 12, 2019 as substantially equivalent to K133597 (Cook, Inc., 2014) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 1992. 1 of the 48 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Dec 12, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 4 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 8 generations to K920547 (1992). 47 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 7 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- 6 generations backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- 5 generations backK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- 4 generations backK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- 3 generations backK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004 · Recalled
- 2 generations backK133597 Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue…Cook, Inc. · 2014 · Recalled
- 1 generation backK180034 Weinmann Tracheostomy Exchange SetCook Incorporated · 2018
- This deviceK193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue…Cook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −7 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| −6 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| −5 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| −4 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| −3 | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | 1 |
| −2 | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino… | Cook, Inc. | 2014 | 1 |
| −1 | K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018 | — |
| 0 (this device) | K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino… | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Summary page 6…lia Blue Rhino Percutaneous Tracheostomy Introducer Set and Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray were cleared under K133597 on April 18, 2014. • The Weinmann Tracheostomy Exchange Set was cleared under K180034 on May 7, 2018. Comparison to… | 2014 |
| * | K180034 | Weinmann Tracheostomy Exchange SetSummary page 6…vanced Percutaneous Tracheostomy Introducer Set/Tray were cleared under K133597 on April 18, 2014. • The Weinmann Tracheostomy Exchange Set was cleared under K180034 on May 7, 2018. Comparison to Predicate: The proposed Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1780-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Mar 5, 2026 | Class II | Z-1779-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Apr 7, 2023 | Class I | Z-1427-2023 | Nonconforming Material/Component | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the… |
| Apr 7, 2023 | Class I | Z-1428-2023 | Nonconforming Material/Component | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 8 of the 47 ancestors have a recall of any class.
- 1 other device also cites its predicate K133597.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for…
Read the full statement (103 words)
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193133
Report an extraction error
Are you the manufacturer?
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