# K062811: Dpilog, Model DPC-512

- Pathway: 510(k) (Traditional)
- Applicant: Life Outcomes, Inc.
- Decided: Dec 20, 2006 after 92 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823423 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990185: Mdilog, Model MDC-512, Medtrak Technologies, Inc. (1999) Summary page 1.
- K970344: Mdilog, Model MDC-511, Medtrak Technologies, Inc. (1997) Summary page 1.
- K935955: DOSER, Newmed Corp. (1994). 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”.

## Indications for use
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.

Source page: https://510kreport.com/device/K062811
Methodology: https://510kreport.com/methodology