510(k) · Cleared
Recalled · 2003Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Feb 24, 1998 as substantially equivalent to K960429 (Smiths Industries Medical Systems, Inc., 1996) after an 18-day review. Its family tree reaches back 2 generations to 1990. 4 of the 36 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled once.
- Decided
- Feb 24, 1998
- Review
- 18 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903730 (1990). 4 ancestors in all. 31 later devices descend from it, 4 citing it directly. 4 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 1 generation backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- This deviceK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998
- Descendant · cites it directly · 21 of its ownK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- Descendant · 2 generations on · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · cites it directly · 8 of its ownK030381 Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable…Portex, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- Descendant · 3 generations on · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K173384 BLUselect, non-fenestrated, BLUselect…2 generations on · 2018
- K173912 BLUperc Percutaneous Dilation Tracheostomy Kit…2 generations on · 2018
- K091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with…3 generations on · 2009
- K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy…3 generations on · 2019
Most influential descendants
Showing 5 of 31 · See all- K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003 · cites it directly21descendants
- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · 2 generations on12descendants
- K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd. · 2003 · cites it directly8descendants
- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · 3 generations on6descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −1 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| 0 (this device) | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | — |
| +1 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| +2 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +1 | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula | Portex, Ltd. | 2003 | 2 |
| +3 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| +3 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 2 |
| 2019 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
4 devices in this family have 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 |
|---|---|---|---|
| * | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner CannulaSummary page 1…, 73 JOH, 21 CFR 868.5800. PREDICATE DEVICE Our current PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K960429 and Cook Critical Care’s Ciaglia Percutaneous Tracheostomy Introducer Set. 23 DESCRIPTION The PER-FIT™ Percutan… | 1996 |
| * | — | Ciaglia Percutaneous Tracheostomy Introducer Set Named without a submission number |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | 2003 | 21 |
| K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula | 2003 | 8 |
| K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single… | 2004 | 5 |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy Kit | 2003 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2003 | Not classified | Z-0569-04 | Other | Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 115 Class I recalls
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030570 (Portex, Ltd., 2003) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K960429.
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.
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?
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
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/K980466 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980466
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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