# K083375: Renasys GO Negative Pressure Wound Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 25, 2009 after 103 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945062 (1995). 16 ancestors in all.
56 later devices descend from it; 6 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082426: Renasys EZ, Smith & Nephew, Inc. (2008) Summary page 1.
- K070904: Antlia II Suction Pump System, Innovative Therapies, Inc. (2007) Summary page 1.
- K080357: Medela Invia Wound Therapy, Medela AG (2008) Summary page 1.

## Most influential descendants
- K111170: PICO (2011), 26 descendants of its own
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own
- K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 (2009), 15 descendants of its own
- K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy (2010), 14 descendants of its own

## Recalls of this device
- Nov 11, 2016 · Class II · Z-1042-2017: Lack of 510k clearance for design modification.
- Nov 11, 2016 · Class II · Z-1041-2017: Lack of 510k clearance for design modification.

## Indications for use
Renasys TM GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: Chronic Acute Traumatic Sub-Acute and dehisced wounds Ulcers (such as pressure or diabetic) Partial-thickness burns Flaps and grafts

Source page: https://510kreport.com/device/K083375
Methodology: https://510kreport.com/methodology