510(k) · Cleared
Recalled · Class II · 2016Parker Flex-Tip Tracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Medical Assoc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jul 15, 1999 as substantially equivalent to K822082 (Sheridan Catheter Corp., 1982) after a 206-day review. Its family tree reaches back 1 generation to 1982. 2 of the 20 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled once.
- Decided
- Jul 15, 1999
- Review
- 206 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822082 (1982). 18 later devices descend from it, 2 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- This deviceK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999
- Descendant · cites it directly · 16 of its ownK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- Descendant · 2 generations on · 14 of its ownK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- Descendant · 3 generations on · 4 of its ownK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- Descendant · 4 generations on · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- Descendant · 3 generations on · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K052233Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005 · cites it directly16descendants
- K082420Tracheoscopic Ventilation Tube (TVT)Etview · 2008 · 2 generations on14descendants
- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · 3 generations on4descendants
- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · 4 generations on3descendants
- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| 0 (this device) | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | — |
| +1 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| +2 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| +3 | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| +4 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| +3 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
2 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 12.6 · 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? (1)
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 |
|---|---|---|---|
| * | K822082 | Sheridan/HVT,CF, UncuffedSummary page 1…ube Common name: Cuffed tracheal tube Classification name: Tracheal tube Classification: Class II, 21 CFR 868.5730 Predicate device: Kendall Sheridan CF Tracheal Tube (K822082) JUL-13-1993 @9:44 PARKER MEDICAL 5133212097 P.g4 510(k) Summary Page 2 Product Description: The Parker trache… | 1982 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2016 | Class II | Z-1399-2017 | Under Investigation by firm | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. |
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.
What does this lineage say?
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
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 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 | — |
What is it indicated for?
Parker cuffed tubes are designed for oral intubation and are indicated for airway management.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984528: Parker Flex-Tip Tracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984528
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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