510(k) · Cleared
Recalled · Class I · 2024BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on May 8, 2018 as substantially equivalent to K041348 (Smiths Medical, 2004) and 1 other predicate after a 137-day review. Its family tree reaches back 6 generations to 1992. 1 of the 47 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- May 8, 2018
- Review
- 137 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K920547 (1992). 46 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 5 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- 4 generations backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- 3 generations backK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- 2 generations backK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- 1 generation backK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004 · Recalled
- This deviceK173912 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube…Smiths Medical Asd, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −5 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| −4 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| −3 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| −2 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| −1 | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | 1 |
| 0 (this device) | K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc… | Smiths Medical Asd, Inc. | 2018 | — |
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 |
| 2006 | 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 |
|---|---|---|---|
| * | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Summary page 6…DA 510(k) Classification Primary Code Device Name Number and Clearance Date UltraPerc K041348 Class II JOH Percutaneous Dilation July 13, 2004 21 CFR 868.5800… | 2004 |
| * | K060945 | Portex Percutaneous Tracheostomy KitSummary page 6…510(k) Classification Product Code Device Name Number and Clearance Date Portex Percutaneous K060945 Class II BTO Tracheostomy Kit Jun 19, 2006 21 CFR 868.5800… | 2006 |
| † | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers… | 2004 |
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 |
|---|---|---|---|---|
| Jun 7, 2024 | Class I | Z-3086-2024 | Process control | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 7 of the 46 ancestors have a recall of any class.
- 2 other devices also cite its predicate K041348.
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. 2018, 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?
Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique.
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into the trachea, which are then used to dilate the trachea.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173912: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173912
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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