# K970344: Mdilog, Model MDC-511

- Pathway: 510(k) (Traditional)
- Applicant: Medtrak Technologies, Inc.
- Decided: Aug 6, 1997 after 189 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: 1 generation back to K823423 (1982). 3 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935955: DOSER, Newmed Corp. (1994) Summary page 1.
- K940835: Peaklog and Display Software, Medtrac Technologies Corp. (1994) Summary page 1.
- K823423: Nebulizer Chronolog & Interpreter, Advanced Technology Products, Inc. (1982) Summary page 1.

## 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 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.

Source page: https://510kreport.com/device/K970344
Methodology: https://510kreport.com/methodology