510(k) · Cleared
Recalled · Class II · 2017MADgic Laryngo-Tracheal Mucosal Atomization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Cleared on Aug 19, 2016 as substantially equivalent to K002255 (Wolfe Tory Medical, Inc., 2000) after a 261-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Aug 19, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- CCT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002255 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002255 Laryngo-Tracheal Mucosal Atomization Device (Madgic)Wolfe Tory Medical, Inc. · 2000
- This deviceK153470 MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical · 2016
- Descendant · cites it directly · 0 of its ownK240114 UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor · 2024
Most influential descendants
Showing 1 of 1 · See all- K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002255 | Laryngo-Tracheal Mucosal Atomization Device (Madgic) | Wolfe Tory Medical, Inc. | 2000 | — |
| 0 (this device) | K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | 2016 | — |
| +1 | K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
Planning a device in CCT? 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 CCT device
- #1 K240114 UltraEzAir® (UEA1A)score 8.5 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K002255 | Laryngo-Tracheal Mucosal Atomization Device (Madgic)Summary page 4…This submission demonstrates substantial equivalence to the predicate device MADgic™ Laryngo-Tracheal Mucosal Atomization Device which was cleared in submission K002255. Device Description The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable non- sterile device that conve… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2017 | Class II | Z-3212-2017 | Process control | Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label. |
| Oct 27, 2016 | Class II | Z-0383-2017 | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| Oct 27, 2016 | Class II | Z-0384-2017 | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CCT devicesCCT Applicator (Laryngo-Tracheal), Topical Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · CCT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CCT
Too few CCT 510(k)s in any year since 2007 to give a median.
Recalls per year · CCT
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCT
2in 2025
MAUDE reports naming product code CCT, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MADgic Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153470: MADgic Laryngo-Tracheal Mucosal Atomization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153470
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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