510(k) · Cleared
Recalled · Class I · 2019Sheridan/HVT,CF, Uncuffed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheridan Catheter Corp. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 10, 1982 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 23 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 27 times, including 17 Class I recalls.
- Decided
- Aug 10, 1982
- Review
- 29 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 27 (17 Class I)
- Predicates
- 0
22 later devices descend from it, 2 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- This deviceK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982
- Descendant · cites it directly · 18 of its ownK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- Descendant · 2 generations on · 16 of its ownK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- Descendant · 3 generations on · 14 of its ownK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- Descendant · 4 generations on · 4 of its ownK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- Descendant · 5 generations on · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
1999high 3 (2009) · low 0 (2000)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K984528Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · cites it directly18descendants
- K052233Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005 · 2 generations on16descendants
- K082420Tracheoscopic Ventilation Tube (TVT)Etview · 2008 · 3 generations on14descendants
- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · 4 generations on4descendants
- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | — |
| +1 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| +2 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| +3 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| +4 | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| +5 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 1 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have 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 12.5 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2019 | Class I | Z-2313-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2316-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2312-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2317-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2318-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2311-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2315-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jul 30, 2019 | Class I | Z-2314-2019 | Process control | 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 may result in insufficient oxygenation… |
| Jun 7, 2019 | Class I | Z-1956-2019 | Device Design | 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 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1762-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1760-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1765-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1759-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1761-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1763-2019 | Process control | 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 becoming disconnected from the… |
| May 24, 2019 | Class I | Z-1764-2019 | Process control | 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 becoming disconnected from the… |
| Oct 18, 2016 | Class II | Z-1177-2017 | Other | 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 | Error in labeling | 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 mix-ups | 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 | Process control | 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 | Process control | The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings. |
| Jul 6, 2009 | Not classified | Z-1891-2009 | Process control | The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings. |
| Sep 27, 2006 | Not classified | Z-0126-2007 | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
| Sep 27, 2006 | Not classified | Z-0128-2007 | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
| Sep 27, 2006 | Not classified | Z-0127-2007 | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
| Jan 14, 2005 | Not classified | Z-0582-05 | Other | 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 the tracheal tube. |
The 5 latest of 27 recalls; the web page lists all.
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
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K984528 (Parker Medical Assoc., 1999) has gone furthest, with 18 descendants of its own.
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.
FDA decisions per year · BTR
7in 2025
2007high 7 (2008) · low 1 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
2007high 308 (2014) · low 61 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
2007high 21 (2009) · low 0 (2008)2026
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
2007high 1,799 (2025) · low 136 (2007)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 | — |
https://510kreport.com/device/K822082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K822082: Sheridan/HVT,CF, Uncuffed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822082
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026