# K181929: MiMo (TM) Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Baymax Research, Inc.
- Decided: Mar 27, 2019 after 252 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K945062 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180840: UNO Negative Pressure Wound Therapy System, Genadyne Biotechnologies, Inc. (2018). Cleared while this submission was under review Summary page 4.

## Indications for use
The MiMo™ Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions MiMo™ Negative Pressure Wound Therapy System is a single patient use device.

Source page: https://510kreport.com/device/K181929
Methodology: https://510kreport.com/methodology