# K200223: PocketDoc™ Micro Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Pensar Medical, LLC
- Decided: Oct 23, 2020 after 268 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: 9 generations back to K945062 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151436: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical, Ltd. (2016) Summary page 4.

## Indications for use
PocketDoc Micro Wound Therapy System is indicated for patients who may benefit from a suction device as it may promote wound healing through the removal of low to moderate levels of exudate 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 PocketDoc Micro Wound Therapy System is suitable for use in both a healthcare and homecare setting.

Source page: https://510kreport.com/device/K200223
Methodology: https://510kreport.com/methodology