# K143301: NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Healing Technologies
- Decided: Mar 3, 2015 after 106 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: 7 generations back to K945062 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123507: Kci NPWT Gauze Dressing, Kci USA, Inc. (2013) Summary page 4.
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys, Smith & Nephew, Inc. (2011) Summary page 4.

## Indications for use
The NewEra REVA Kit is intended to be used with the NewEra pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and perfusion, and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: * Pressure Ulcers * Diabetic/neuropathic ulcers * Venous insufficiency ulcers * Chronic, Acute, Traumatic, and Subacute wounds * Post-operative and dehisced surgical wounds + Skin flaps and grafts

Source page: https://510kreport.com/device/K143301
Methodology: https://510kreport.com/methodology