510(k) · Cleared
Recalled · 2007Per-Fit Percutaneous Dilational Tracheostomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jul 18, 2003 as substantially equivalent to K980466 (Sims Portex, Inc., 1998) and 4 other predicates after a 106-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jul 18, 2003
- Review
- 106 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 7
- Predicates
- 5
Its longest line of descent runs back 3 generations to K903730 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 2 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 1 generation backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- This deviceK031057 Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK050166 Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005
Most influential descendants
Showing 1 of 1 · See all- K050166Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −2 | 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 |
| 0 (this device) | K031057 | Per-Fit Percutaneous Dilational Tracheostomy Kit | Portex, Inc. | 2003 | — |
| +1 | K050166 | Portex Emergency Cricothyroidotomy Kit | Smiths Medical | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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.
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 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? (5)
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 |
|---|---|---|---|
| * | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Summary page 1…ATE DEVICES Predicate 1 : Our current PER-FITTMPercutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K980466[K960429]. This is the main predicate device, cited for materials/biocompatibility and for most design character… | 1998 |
| * | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner CannulaSummary page 1…CES Predicate 1 : Our current PER-FITTMPercutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K980466[K960429]. This is the main predicate device, cited for materials/biocompatibility and for most design characteristics.… | 1996 |
| * | K934465 | Dic Tracheostomy Tube and Portex Blue LineSummary page 2…ristics. 29 smiths Predicate 2: Our DIC (Disposable Inner Cannula) Tracheostomy Tube, K934465[K903730]. This predicate device is cited, in conjunction with Predicate 1 above, for the tube/inner cannula shape a… | 1994 |
| * | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy TubesSummary page 2…29 smiths Predicate 2: Our DIC (Disposable Inner Cannula) Tracheostomy Tube, K934465[K903730]. This predicate device is cited, in conjunction with Predicate 1 above, for the tube/inner cannula shape and dista… | 1990 |
| * | K011210 | The Percuquick Set for Percutaneous Dilation Tracheostomy | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050166 | Portex Emergency Cricothyroidotomy Kit | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2007 | Not classified | Z-0100-2008 | Process control | Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube. |
| May 16, 2005 | Not classified | Z-0872-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| May 16, 2005 | Not classified | Z-0867-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| May 16, 2005 | Not classified | Z-0869-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| May 16, 2005 | Not classified | Z-0870-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| May 16, 2005 | Not classified | Z-0868-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| May 16, 2005 | Not classified | Z-0871-05 | Other | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K050166 (Smiths Medical, 2005) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K980466.
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 as stated in the FDA summary.
https://510kreport.com/device/K031057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031057: Per-Fit Percutaneous Dilational Tracheostomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031057
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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