510(k) · Cleared
ClearedLaryngo-Tracheal Mucosal Atomization Device (Madgic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wolfe Tory Medical, Inc. · CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Cleared on Sep 18, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Sep 18, 2000
- Review
- 55 days
- Class
- Class II
- Product code
- CCT
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK002255 Laryngo-Tracheal Mucosal Atomization Device (Madgic)Wolfe Tory Medical, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK153470 MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK122023 Mixject with Spray HeadMedimop Medical Projects, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK070596 Topical ApplicatorSharn, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK240114 UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor · 2024
- Descendant · 2 generations on · 0 of its ownK130179 MP Vial Adapter 13MMMedimop Medical Projects, Ltd. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical · 2016 · cites it directly1descendant
- K122023Mixject with Spray HeadMedimop Medical Projects, Ltd. · 2012 · cites it directly1descendant
- K070596Topical ApplicatorSharn, Inc. · 2007 · cites it directly1descendant
- K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor · 2024 · 2 generations on0descendants
- K130179MP Vial Adapter 13MMMedimop Medical Projects, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002255 | Laryngo-Tracheal Mucosal Atomization Device (Madgic) | Wolfe Tory Medical, Inc. | 2000 | — |
| +1 | K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | 2016 | 3 |
| +1 | K122023 | Mixject with Spray Head | Medimop Medical Projects, Ltd. | 2012 | — |
| +1 | K070596 | Topical Applicator | Sharn, Inc. | 2007 | 3 |
| +2 | K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | 2024 | — |
| +2 | K130179 | MP Vial Adapter 13MM | Medimop Medical Projects, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153470 (Teleflex Medical, 2016) has gone furthest, with 1 descendant of its own.
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.
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 | — |
https://510kreport.com/device/K002255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002255: Laryngo-Tracheal Mucosal Atomization Device (Madgic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002255
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026