510(k) · Cleared
ClearedPortex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 13, 2008 as substantially equivalent to K965132 (Mallinckrodt Medical, 1997) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 1990. 1 of the 14 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 13, 2008
- Review
- 119 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903730 (1990). 10 ancestors in all, the oldest K811033 (1981). 3 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 3 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 2 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 1 generation backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- This deviceK081086 Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size…Smiths Medical Asd, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion…Teleflexmedical, Inc. · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK141939 Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion…Teleflexmedical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
- K091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with…cites it directly · 2009
Most influential descendants
Showing 3 of 3 · See all- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · cites it directly2descendants
- K141939Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Teleflexmedical, Inc. · 2014 · 2 generations on1descendant
- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −3 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −2 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −1 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| 0 (this device) | K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and… | Smiths Medical Asd, Inc. | 2008 | — |
| +1 | K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port | Teleflexmedical, Inc. | 2009 | Class I |
| +2 | K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction… | Teleflexmedical, Inc. | 2014 | — |
| +3 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2009 | 1 | 1 |
| 2014 | 1 | 0 |
| 2019 | 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.
1 device in this family has 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 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? (3)
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 |
|---|---|---|---|
| * | K965132 | HI-LO Evac and Evac II Endotracheal TubesSummary page 1…and.CT21 6JL1 Phone.: 00 44 (0)1303 260551 Fax: 00 44 (0)303 262798 Equivalent to: Hi-LoTm Evac Endotracheal Tube - K965 132 Portex® Tracheal Tube - already marketed in the USA from 1976 under pre-amendment ar… | 1997 |
| * | K030570 | Blue Line Ultra Suctionaid Tracheostomy TubeSummary page 1…ready marketed in the USA from 1976 under pre-amendment arrangement. Portex® Blue Line® Ultra Suctionaid Tracheostomy Tube - K030570 Device Description: Single use Tracheal tube with integral suction line for lavage and evacuation above… | 2003 |
| * | — | Portex Tracheal Tube Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port Class I | 2009 | 2 |
Has anything in its family been recalled? (1 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.
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 115 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K091761 (Teleflexmedical, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K965132.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Portex® Blue Line® SACETT™ is intended for oral intubation only for airway management of patients anticipated to require prolonged mechanical ventilation in critical care units. The product may be inserted in the emergency room or pre-hospital to avoid the need for reintubation, SACETT™'s dorsal suction lumen allows drainage by continuous or intermittent suctioning of contaminated mucous and subglottis secretion that accumulate above the cuff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081086: Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081086
Report an extraction error
Are you the manufacturer?
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