510(k) · Cleared
ClearedCuff Pilot, Sure Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on May 8, 2015 as substantially equivalent to K102704 (Joan Spiegel, MD, 2011) and 1 other predicate after a 280-day review. Its family tree reaches back 7 generations to 1990. 3 later devices descend from it.
- Decided
- May 8, 2015
- Review
- 280 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K903730 (1990). 23 ancestors in all, the oldest K811033 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 6 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 5 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 4 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 3 generations backK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- 2 generations backK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- 1 generation backK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- This deviceK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK182548 Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · cites it directly1descendant
- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · 2 generations on0descendants
- K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −6 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −5 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −4 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −3 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| −2 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| −1 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| 0 (this device) | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +1 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +2 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
| +1 | K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 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 BSK? 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 BSK device
- #1 K261499 TrachFlushscore 13.0 · 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? (2)
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 |
|---|---|---|---|
| * | K102704 | Easy CuffSummary page 5…Airway, oropharyngeal CAE – 21 CFR 868.5110, Class I Predicate Devices: Easy Cuff – K102704 LMA™ Classic – K130304 Device Description: The Cuff Pilot™ is a simple device which al… | 2011 |
| * | K130304 | Lma Family of AirwaysSummary page 5…CAE – 21 CFR 868.5110, Class I Predicate Devices: Easy Cuff – K102704 LMA™ Classic – K130304 Device Description: The Cuff Pilot™ is a simple device which allows the user to monitor the cuff pressure of supraglottic airway… | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K160694 (Tianjin Medis Medical Device Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K102704.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · BSK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSK
376in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSK
1in 2017
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSK
46in 2025
MAUDE reports naming product code BSK, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 171 | 0 | 15 |
| 2012 | 2 | — | 0 | 62 |
| 2013 | 1 | — | 1 (1) | 16 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 4 | 376 | 0 | 1 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 2 | — | 0 | 46 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
To monitor intra-cuff pressures of supraglottic airways. Patient Population: Patients who have an artificial airway and for which the user would like to monitor cuff pressure, pediatric to adult. Environments of Use: To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may have an artificial airway. It may also be used in MRI suites when attached to airways that are MR…
Read the full statement (227 words)
To monitor intra-cuff pressures of supraglottic airways.
Patient Population:
Patients who have an artificial airway and for which the user would like to monitor cuff pressure, pediatric to adult.
Environments of Use:
To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may have an artificial airway. It may also be used in MRI suites when attached to airways that are MR conditional or MR Safe.
The SureSeal™ supraglottic airway with attached Cuff Pilot TM is indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients and emergency procedures using either spontaneous or Positive Pressure Ventilation (PPV).
• An alternative to a face mask.
• An airway device in routine anesthesia procedures.
• Securing the immediate airway in anticipated or unexpected difficult airway situations.
• Use in elective surgical procedures where tracheal intubation is not necessary.
• Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly unconscious patient requiring artificial ventilation when tracheal intubation is not possible.
Patient Population:
Patients who need an artificial airway, pediatric to adult.
Environments of Use:
To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient needs an artificial airway. It may also be used in MRI suites and is considered MRI Safe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142103: Cuff Pilot, Sure Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142103
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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