510(k) · Cleared
ClearedCapMedic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cognita Labs, LLC · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 13, 2019 as substantially equivalent to K990185 (Medtrak Technologies, Inc., 1999) and 2 other predicates after a 266-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Sep 13, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K823423 (1982). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 4 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 3 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 2 generations backK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- 1 generation backK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- This deviceK183586 CapMedicCognita Labs, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −4 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −3 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −2 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| −1 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| 0 (this device) | K183586 | CapMedic | Cognita Labs, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K990185 | Mdilog, Model MDC-512Summary page 4…8.1840, Class II, Diagnostic spirometer (a)(3) An identification of the legally marketed devices The predicate devices to which substantial equivalence is claimed are: K990185, MDILog System MDC-512 marketed by Medtrac Technologies, Inc., K140638, Propeller Model 2 Sensor marketed by Reciprocal Labs Corp… | 1999 |
| * | K140638 | Propeller System - Model 2Summary page 4…he legally marketed devices The predicate devices to which substantial equivalence is claimed are: K990185, MDILog System MDC-512 marketed by Medtrac Technologies, Inc., K140638, Propeller Model 2 Sensor marketed by Reciprocal Labs Corporation, and K133722 Asthma Monitor AM3 GSM (PEF and FEV1 meter) market… | 2014 |
| * | K133722 | Asthma Monitor AM3Summary page 4…nce is claimed are: K990185, MDILog System MDC-512 marketed by Medtrac Technologies, Inc., K140638, Propeller Model 2 Sensor marketed by Reciprocal Labs Corporation, and K133722 Asthma Monitor AM3 GSM (PEF and FEV1 meter) marketed by eResearchTechnology. (a)(4) A description of the device The CapMedic devi… | 2014 |
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 37 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K990185.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician. The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures…
Read the full statement (239 words)
The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.
The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures the parameters of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection.
CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.
The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.
CapMedic may be used with any of the following MDIs: Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183586: CapMedic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183586
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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