510(k) · Cleared
ClearedMdi Tutor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mdi Tutor, Inc. · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Cleared on Aug 14, 1996 after a 90-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 14, 1996
- Review
- 90 days
- Class
- Class I
- Product code
- CCQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CCQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | AeroChamber Named without a submission number | |
| * | — | InspirEase Named without a submission 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 CCQ devicesCCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCQ
FDA has decided no CCQ device since 2007.
Median 510(k) review, days · CCQ
Too few CCQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CCQ
5in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCQ
30in 2025
MAUDE reports naming product code CCQ, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 207 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 132 |
| 2016 | 0 | — | 5 | 18 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDISs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961894: Mdi Tutor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961894
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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