# K142103: Cuff Pilot, Sure Seal

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: May 8, 2015 after 280 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K903730 (1990). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102704: Easy Cuff, Joan Spiegel, MD (2011) Summary page 5.
- K130304: Lma Family of Airways, The Laryngeal Mask Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own
- K182548: Accucuff Cuff Pressure Indicator (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K142103
Methodology: https://510kreport.com/methodology