510(k) · Cleared
Recalled · 2009Topical Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharn, Inc. · CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Cleared on Jun 21, 2007 as substantially equivalent to K002255 (Wolfe Tory Medical, Inc., 2000) and 1 other predicate after a 111-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jun 21, 2007
- Review
- 111 days
- Class
- Class II
- Product code
- CCT
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852544 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K093584EZ-MisterN.M. Beale Co., Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852544 | Monoject Sterile 3CC Syringes W/ & WO/ Needles | Sherwood Medical Co. | 1985 | 1 |
| 0 (this device) | K070596 | Topical Applicator | Sharn, Inc. | 2007 | — |
| +1 | K093584 | EZ-Mister | N.M. Beale Co., Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (2)
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 1…ation Code: CCT - 21 CFR 868.5170 Device: Topical Applicator Predicate Devices: Wolfe Tory - MADgic - K002255 Sherwood Monoject syringe - K852544 Device Description: The Topical applicato… | 2000 |
| * | K852544 | Monoject Sterile 3CC Syringes W/ & WO/ NeedlesSummary page 1…Topical Applicator Predicate Devices: Wolfe Tory - MADgic - K002255 Sherwood Monoject syringe - K852544 Device Description: The Topical applicator incorporates a small tube with atomizing… | 1985 |
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 |
|---|---|---|---|
| K093584 | EZ-Mister | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2009 | Not classified | Z-0266-2010 | Device Design | Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. |
| Mar 5, 2009 | Not classified | Z-0267-2010 | Device Design | Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. |
| Mar 5, 2009 | Not classified | Z-0265-2010 | Device Design | Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. |
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. 2007, 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?
Intended for atomizing topical anesthetics to the oropharynx and upper airway regions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070596: Topical Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070596
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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