510(k) · Cleared
ClearedDpilog, Model DPC-512
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Outcomes, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Dec 20, 2006 as substantially equivalent to K990185 (Medtrak Technologies, Inc., 1999) and 2 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Dec 20, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K823423 (1982). 5 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 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −1 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| 0 (this device) | K062811 | Dpilog, Model DPC-512 | Life Outcomes, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 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 1…Accessory to Metered Dose Inhalers Classification Name: Anesthesiology 21 CFR 868.5630 73 CAF Predicate Device: MedTrac MDILog MDC-512, K990185, cleared April 1, 1999 MedTrac MDILog MDC-511, K970344, cleared August 6,1997 N… | 1999 |
| * | K970344 | Mdilog, Model MDC-511Summary page 1…21 CFR 868.5630 73 CAF Predicate Device: MedTrac MDILog MDC-512, K990185, cleared April 1, 1999 MedTrac MDILog MDC-511, K970344, cleared August 6,1997 NewMed Doser, K936955, cleared September 516, 1994 Device Description: The DPILo… | 1997 |
| * | K935955 | DOSER Our reading of the summary gave K936955, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NewMed Doser”. | 1994 |
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 24 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 5 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.
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 DPILog is intended for use by a single patient under the care or treatment of a
physician or licensed healthcare professional. The DPILog is prescribed by the
doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The
DPILog can be used by any patient who regularly uses DPIs as prescribed by a
physician.
It will be the physician or healthcare professional's responsibility to contact and
coordinate with Life Outcomes to acquire and attach the DPILog electronics module,
disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog
electronic modules and disposable sleeve bodies will be distributed to patients by a
physician or healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062811: Dpilog, Model DPC-512.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062811
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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