# K780900: Slick Set

- Pathway: 510(k) (Traditional)
- Applicant: Polamedco, Inc.
- Decided: Jul 17, 1978 after 63 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 28 (26 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 25, 2023 · Class I · Z-1841-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1829-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1843-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1842-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1901-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1904-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1837-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1840-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1905-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1897-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1836-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1838-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1902-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1832-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1831-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1830-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1834-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1839-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1835-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1903-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1827-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1844-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1900-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1860-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1833-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1828-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- Dec 8, 2022 · Class II · Z-1010-2023: Potential for pilot balloon non-inflation or cuff non-deflation.
- Jul 16, 2021 · Class II · Z-2319-2021: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Source page: https://510kreport.com/device/K780900
Methodology: https://510kreport.com/methodology