510(k) · Cleared
ClearedEzc Medical, LLC Intubaidflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezc Medical, LLC · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 4, 2009 as substantially equivalent to K082420 (Etview, 2008) after a 134-day review. Its family tree reaches back 4 generations to 1982. 1 of the 9 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 4, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K822082 (1982). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 3 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 2 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 1 generation backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- This deviceK090777 Ezc Medical, LLC IntubaidflexEzc Medical, LLC · 2009
- Descendant · cites it directly · 1 of its ownK152438 ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK250243 ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)…Flexicare Medical Limited. · 2025
- Descendant · cites it directly · 0 of its ownK093186 Ambu Ascope and MonitorAmbu A/S · 2010
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffed4 generations back · 1982
Most influential descendants
Showing 3 of 3 · See all- K152438ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016 · cites it directly1descendant
- K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…Flexicare Medical Limited. · 2025 · 2 generations on0descendants
- K093186Ambu Ascope and MonitorAmbu A/S · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −3 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −2 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −1 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| 0 (this device) | K090777 | Ezc Medical, LLC Intubaidflex | Ezc Medical, LLC | 2009 | — |
| +1 | K152438 | ETView VivaSight-SL (TVT) system | Etview, Ltd. | 2016 | — |
| +2 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)… | Flexicare Medical Limited. | 2025 | — |
| +1 | K093186 | Ambu Ascope and Monitor | Ambu A/S | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K082420 | Tracheoscopic Ventilation Tube (TVT)Summary page 2…e Device: The EZC Medical's IntubaidFlex TM is substantially equivalent to ETView Tra- cheoscopic Ventilation Tube (TVTTM) in intended use and operation (K082420). Both the devices are endoscopic, and transmit images through a video camera to a video monitor and use a light… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 4 generations back · ◆ on the line of descent in FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152438 (Etview, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082420.
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. 2009, this device’s year, is highlighted.
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?
The IntubaidFlexTM is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090777: Ezc Medical, LLC Intubaidflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090777
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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