# K822082: Sheridan/HVT,CF, Uncuffed

- Pathway: 510(k) (Traditional)
- Applicant: Sheridan Catheter Corp.
- Decided: Aug 10, 1982 after 29 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 27 (17 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
3 of 23 devices in its family (counting itself) have 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.

## Most influential descendants
- K984528: Parker Flex-Tip Tracheal Tube (1999), 18 descendants of its own
- K052233: Tracheoscopic Ventilation Tube (TVT) System (2005), 16 descendants of its own
- K082420: Tracheoscopic Ventilation Tube (TVT) (2008), 14 descendants of its own
- K113576: Double Lumen Video Tracheosdope (DLVT) System (2012), 4 descendants of its own
- K123853: Vivasight-DL System (2013), 3 descendants of its own

## Recalls of this device
- Jul 30, 2019 · Class I · Z-2313-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2316-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2312-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2317-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2318-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2311-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2315-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jul 30, 2019 · Class I · Z-2314-2019: Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit ma
- Jun 7, 2019 · Class I · Z-1956-2019: Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
- May 24, 2019 · Class I · Z-1766-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1762-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1760-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1765-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1759-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1761-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1763-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- May 24, 2019 · Class I · Z-1764-2019: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector beco
- Oct 18, 2016 · Class II · Z-1177-2017: Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
- May 5, 2016 · Class II · Z-1938-2016: The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
- Jan 9, 2015 · Class II · Z-1078-2015: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
- Nov 12, 2014 · Class II · Z-0799-2015: Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
- Jul 6, 2009 · Not classified · Z-1890-2009: The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
- Jul 6, 2009 · Not classified · Z-1891-2009: The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
- Sep 27, 2006 · Not classified · Z-0126-2007: Biological indicator failed. Investigation eliminated all equipment and product related factors.
- Sep 27, 2006 · Not classified · Z-0128-2007: Biological indicator failed. Investigation eliminated all equipment and product related factors.
- Sep 27, 2006 · Not classified · Z-0127-2007: Biological indicator failed. Investigation eliminated all equipment and product related factors.
- Jan 14, 2005 · Not classified · Z-0582-05: Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of 

Source page: https://510kreport.com/device/K822082
Methodology: https://510kreport.com/methodology