510(k) · Cleared
ClearedBlue Line Ultra Suctionaid Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Sep 17, 2003 as substantially equivalent to K912124 (Concord/Portex, 1991) and 5 other predicates after a 205-day review. Its family tree reaches back 3 generations to 1990. 2 of the 31 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- Sep 17, 2003
- Review
- 205 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K903730 (1990). 9 ancestors in all, the oldest K811033 (1981). 21 later devices descend from it, 3 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- 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 deviceK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- Descendant · cites it directly · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · 2 generations on · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
- Descendant · cites it directly · 4 of its ownK173384 BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont…Smiths Medical Ads, Inc. · 2018 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · cites it directly12descendants
- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · 2 generations on6descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · 2 generations on5descendants
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Smiths Medical Ads, Inc. · 2018 · cites it directly4descendants
- K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014 · 3 generations on4descendants
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) | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| +1 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +2 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| +2 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
| +1 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect… | Smiths Medical Ads, Inc. | 2018 | Class I |
| +3 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2019 | 2 | 0 |
| 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.
2 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 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? (6)
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 |
|---|---|---|---|
| * | K912124 | Tracheostomy Tube and CuffSummary page 1…Tracheostomytube. Class I1 BTO, 21 CFR 868.5800 PREDICATE DEVICES: e Portex Inc Flexible D.1.C Tracheostomytube, already marketed in the USA under K912124 e Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, already marketed in the USA under K81103… | 1991 |
| * | K811033 | Shiley Low Pressure Thin-Cuffed TrachSummary page 1…ube, already marketed in the USA under K912124 e Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, already marketed in the USA under K811033. e Portex Inc. Percutaneous Dilatory tracheostomyKit with Speciality tracheostomy Tube, already marketed in the USA… | 1981 |
| * | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Summary page 1…in the USA under K811033. e Portex Inc. Percutaneous Dilatory tracheostomyKit with Speciality tracheostomy Tube, already marketed in the USA under IC980466 e Mallinckrodt Hi-LoEvac Tracheal Tube, already mafketed in the USA under K965 132. Portex Inc Sten-Cath Closed Ven… | 1998 |
| * | K965132 | HI-LO Evac and Evac II Endotracheal TubesSummary page 1…yKit with Speciality tracheostomy Tube, already marketed in the USA under IC980466 e Mallinckrodt Hi-LoEvac Tracheal Tube, already mafketed in the USA under K965 132. Portex Inc Sten-Cath Closed Ventilation Suction System already marketed in the USA under K923559 e Bivona Aire-Cuf… | 1997 |
| * | K923559 | Steri-Cath MdiSummary page 1…odt Hi-LoEvac Tracheal Tube, already mafketed in the USA under K965 132. Portex Inc Sten-Cath Closed Ventilation Suction System already marketed in the USA under K923559 e Bivona Aire-Cuf Tracheostomytube with talk attachment already marketed in the USA under K912967 DEVICE DESCRIPTION:… | 1993 |
| * | K912967 | Bivona Aire-Cuf Tracheostomy Tube W/Talk Attach.Summary page 1…osed Ventilation Suction System already marketed in the USA under K923559 e Bivona Aire-Cuf Tracheostomytube with talk attachment already marketed in the USA under K912967 DEVICE DESCRIPTION: The Blue Line Ultra Suctionaid PLUS) tracheostomy tube provides an airway to the patients lungs when… | 1991 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | 2004 | 12 |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated… Class I | 2018 | 4 |
| K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and… | 2008 | 3 |
Has anything in its family been recalled? (2 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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 115 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K032112 (Portex, Ltd., 2004) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K912124.
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.
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?
The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030570: Blue Line Ultra Suctionaid Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030570
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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