510(k) Report

510(k) · Cleared

Cleared

Medicant Mucosal Atomizer

K172956510(k) TraditionalCleared Apr 6, 2018192-day reviewClass II21 CFR 868.5170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medica Holdings, LLC · CCT Applicator (Laryngo-Tracheal), Topical Anesthesia

Cleared on Apr 6, 2018 after a 192-day review. The FDA summary names no predicate by number.

Decided
Apr 6, 2018
Review
192 days
Class
Class II
Product code
CCT
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K172956Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240114 UltraEzAir® (UEA1A)score 8.5 · 2 generations · no Class I recall
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What was it cleared against?

The FDA summary names no predicate by number.

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.

How does its category compare?

All CCT devices

CCT Applicator (Laryngo-Tracheal), Topical Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · CCT

1in 2024

2007: 12011: 12016: 12018: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

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

2009: 32016: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CCT

2in 2025

2010: 32012: 12014: 12015: 42017: 22021: 32022: 32023: 22024: 22025: 2
2007high 4 (2015) · low 0 (2007)2025

MAUDE reports naming product code CCT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—30
20100—03
20111—00
20120—01
20130—00
20140—01
20150—04
20161—10
20170—02
20181—00
20190—00
20200—00
20210—03
20220—03
20230—02
20241—02
20250—02
20260—0—
Cite this page

510(k) Report. “K172956: Medicant Mucosal Atomizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172956

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026