510(k) · Decided
DecidedPer-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on May 2, 1996 as substantially equivalent to K936133 (Smiths Industries Medical Systems, Inc., 1994) and 2 other predicates after a 92-day review. Its family tree reaches back 1 generation to 1990. 4 of the 36 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it.
- Decided
- May 2, 1996
- Review
- 92 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K903730 (1990). 3 ancestors in all. 32 later devices descend from it, 2 citing it directly. 4 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- This deviceK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- Descendant · cites it directly · 31 of its ownK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 21 of its ownK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- Descendant · 3 generations on · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · 2 generations on · 8 of its ownK030381 Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable…Portex, Ltd. · 2003 · Recalled
- Descendant · 4 generations on · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K173384 BLUselect, non-fenestrated, BLUselect…3 generations on · 2018
- K173912 BLUperc Percutaneous Dilation Tracheostomy Kit…3 generations on · 2018
- K091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with…4 generations on · 2009
- K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy…4 generations on · 2019
Most influential descendants
Showing 5 of 32 · See all- K980466Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Sims Portex, Inc. · 1998 · cites it directly31descendants
- K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003 · 2 generations on21descendants
- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · 3 generations on12descendants
- K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd. · 2003 · 2 generations on8descendants
- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| 0 (this device) | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| +1 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| +2 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| +3 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +2 | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula | Portex, Ltd. | 2003 | 2 |
| +4 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K936133 | Percutaneous Tracheostomy KitSummary page 1…acheostomy Tube with Disposable Inner Cannula PRODUCT CLASS/CLASSIFICATION Class II, 73 JOH, 21 CFR 868.5800. PREDICATE DEVICE Our current Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. Also, comparison is being made to the Cook Critical Care Ciaglia… | 1994 |
| * | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy TubesSummary page 1…CT CLASS/CLASSIFICATION Class II, 73 JOH, 21 CFR 868.5800. PREDICATE DEVICE Our current Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. Also, comparison is being made to the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set. === Page… | 1990 |
| * | K912124 | Tracheostomy Tube and CuffSummary page 1…SSIFICATION Class II, 73 JOH, 21 CFR 868.5800. PREDICATE DEVICE Our current Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. Also, comparison is being made to the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set. DESCR… | 1991 |
| * | — | Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set Named without a submission number |
What descends from it? (32)
See all 322 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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 · 3 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 · 3 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 · 4 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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 SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management. The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing tirae required. The Disposable…
Read the full statement (130 words)
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing tirae required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.
The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.
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/K960429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. 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/K960429
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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