510(k) · Cleared
ClearedEZ-Mister
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.M. Beale Co., Inc. · CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Cleared on Mar 4, 2011 as substantially equivalent to K070596 (Sharn, Inc., 2007) after a 470-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Mar 4, 2011
- Review
- 470 days
- Class
- Class II
- Product code
- CCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852544 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852544 | Monoject Sterile 3CC Syringes W/ & WO/ Needles | Sherwood Medical Co. | 1985 | 1 |
| −1 | K070596 | Topical Applicator | Sharn, Inc. | 2007 | 3 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K070596 | Topical ApplicatorSummary page 1…-tracheal, topical anesthesia 21 CFR 868.5170; Class 11 Premarket Notification: K070596 Device Description The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The de… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 21.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
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. 2011, 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 EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093584: EZ-Mister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093584
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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