510(k) · Cleared
ClearedPortex Uniperc Percutaneous Dilation Tracheostomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Aug 18, 2009 as substantially equivalent to K040014 (Portex, Ltd., 2004) and 6 other predicates after a 312-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 18, 2009
- Review
- 312 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K920547 (1992). 53 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet.
- 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 deviceK083031 Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc. · 2009
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) | K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy Kit | Smiths Medical Asd, Inc. | 2009 | — |
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 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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.
Planning a device in BTO? 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 BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers… | 2004 |
| * | K060945 | Portex Percutaneous Tracheostomy KitSummary page 1…Portexo Percutaneous Dilation Tracheostomny Kit with Serial Dilators (KO40014) Portexo Percutaneous (GWDF) Tracheostomy Kit (K060945) Portexo UltraPerc Tracheostomny kits (K04 1348) Smiths Point-Lok Device (K946289)… | 2006 |
| * | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Summary page 1…(KO40014) Portexo Percutaneous (GWDF) Tracheostomy Kit (K060945) Portexo UltraPerc Tracheostomny kits (K04 1348) Smiths Point-Lok Device (K946289) Portex~Blue Line Ultra Tracheostomy tubes (K03 03… | 2004 |
| * | K946289 | Devons Point Lok Needle Protection DeviceSummary page 1…rtexo Percutaneous (GWDF) Tracheostomy Kit (K060945) Portexo UltraPerc Tracheostomny kits (K04 1348) Smiths Point-Lok Device (K946289) Portex~Blue Line Ultra Tracheostomy tubes (K03 03 81) Portex~Adjustable Flange Trach… | 1995 |
| * | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaSummary page 1…Portexo UltraPerc Tracheostomny kits (K04 1348) Smiths Point-Lok Device (K946289) Portex~Blue Line Ultra Tracheostomy tubes (K03 03 81) Portex~Adjustable Flange Tracheostomy Tube (K962175) Portexo Reinforced Tracheal Tub… | 2003 |
| * | K962175 | Portex Adjustable Flange Tracheostomy TubeSummary page 1…Point-Lok Device (K946289) Portex~Blue Line Ultra Tracheostomy tubes (K03 03 81) Portex~Adjustable Flange Tracheostomy Tube (K962175) Portexo Reinforced Tracheal Tubes Cuffed and Uncuffed (K0321 12) Kapitex Inner Cannu… | 1997 |
| * | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Summary page 1…tubes (K03 03 81) Portex~Adjustable Flange Tracheostomy Tube (K962175) Portexo Reinforced Tracheal Tubes Cuffed and Uncuffed (K0321 12) Kapitex Inner Cannula Cleaning Swabs (Class 1 exempt) Device Description: The UniPerCTm device has bee… | 2004 |
| * | — | Kapitex Inner Cannula Cleaning Swabs Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 7 of the 53 ancestors have a recall of any class.
- 1 other device also cites its predicate K040014.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Portex® UniPercTM single use Percutaneous Dilation Tracheostomy Kits allows the controlled, elective subcricoid percutaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldinger guidewire dilation technique in patients with a large neck anatomy (up to a maximum of 50mm of pre-tracheal soft tissue anterior to the trachea) where standard length flange tracheostomy tubes are too short. Tracheostomy tube maximum period of use 29 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083031: Portex Uniperc Percutaneous Dilation Tracheostomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083031
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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