510(k) · Cleared
ClearedMdilog, Model MDC-511
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrak Technologies, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 6, 1997 as substantially equivalent to K935955 (Newmed Corp., 1994) and 2 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1982. 27 later devices descend from it.
- Decided
- Aug 6, 1997
- Review
- 189 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K823423 (1982). 3 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- This deviceK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- Descendant · cites it directly · 25 of its ownK091803 Smarttrack SystemNexus6, Ltd. · 2009
- Descendant · 2 generations on · 13 of its ownK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- Descendant · 3 generations on · 12 of its ownK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- Descendant · 2 generations on · 10 of its ownK133951 SmarttouchNexus6, Ltd. · 2014
- Descendant · 4 generations on · 8 of its ownK142516 Propeller SystemReciprocal Labs Corporation · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K091803Smarttrack SystemNexus6, Ltd. · 2009 · cites it directly25descendants
- K121609Asthmapolis SystemReciprocal Labs Corporation · 2012 · 2 generations on13descendants
- K140638Propeller System - Model 2Reciprocal Labs Corporation · 2014 · 3 generations on12descendants
- K133951SmarttouchNexus6, Ltd. · 2014 · 2 generations on10descendants
- K142516Propeller SystemReciprocal Labs Corporation · 2015 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| 0 (this device) | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| +1 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| +2 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| +3 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| +2 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| +4 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K935955 | DOSERSummary page 1…od, CO 80228 303-985-0252 Date Prepared: January 27, 1997 Substantial Equivalence Statement: MDILog is substantially equivalent to the predicate devices NewMed Doser (K935955), Medtrac Peaklog (K940835) and Nebulizer Chronolog (K823423). Description: The MDILog system monitors the compliance of asthma… | 1994 |
| * | K940835 | Peaklog and Display SoftwareSummary page 1…Date Prepared: January 27, 1997 Substantial Equivalence Statement: MDILog is substantially equivalent to the predicate devices NewMed Doser (K935955), Medtrac Peaklog (K940835) and Nebulizer Chronolog (K823423). Description: The MDILog system monitors the compliance of asthma and chronic respiratory pat… | 1994 |
| * | K823423 | Nebulizer Chronolog & InterpreterSummary page 1…ubstantial Equivalence Statement: MDILog is substantially equivalent to the predicate devices NewMed Doser (K935955), Medtrac Peaklog (K940835) and Nebulizer Chronolog (K823423). Description: The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (… | 1982 |
What descends from it? (27)
See all 272 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?
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed health care professional. The MDILog is prescribed by the doctor when detailed MDI usage monitoring is indicated. The MDILog can be used by any patient who regularly uses MDIs as prescribed by a physician.
It will be the physician or health care professional’s responsibility to contact and coordinate with Medtrac Technologies the attachment of the MDILog adapter and device onto the MDI actuator. MDIs with attached MDILog adapters and devices will be distributed to patients by a physician or health care professional.
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/K970344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970344: Mdilog, Model MDC-511.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970344
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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