# K990185: Mdilog, Model MDC-512

- Pathway: 510(k) (Traditional)
- Applicant: Medtrak Technologies, Inc.
- Decided: Apr 1, 1999 after 71 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
No predicates in its family tree.
27 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091803: Smarttrack System (2009), 25 descendants of its own
- K121609: Asthmapolis System (2012), 13 descendants of its own
- K140638: Propeller System - Model 2 (2014), 12 descendants of its own
- K133951: Smarttouch (2014), 10 descendants of its own
- K142516: Propeller System (2015), 8 descendants of its own

## Indications for use
The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed heelth 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 regularty uses MDIs as prescribed by a physician. 1t will be the physician or health care professional’s responsibility to contact and coordinate with Medtrac Technologies to acquire and attach the MDILog heel adapter, sleeve adapter bodies and MDILog device onto MDI actuators. MDIs with attached MDILog sleeve adapters and devices will be distributed to patients by a physician or health care professional.

Source page: https://510kreport.com/device/K990185
Methodology: https://510kreport.com/methodology