510(k) · Cleared
ClearedRENASYS Y-Connector; RENASYS TOUCH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Medical Limited · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 10, 2019 as substantially equivalent to K153209 (Smith & Nephew Medical, Ltd., 2016) and 2 other predicates after a 248-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Jan 10, 2019
- Review
- 248 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K945062 (1995). 35 ancestors in all, the oldest K914604 (1992). No later device cites it as a predicate yet.
- Root · 11 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations between
- 3 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 2 generations backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- 1 generation backK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- This deviceK181204 RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited · 2019
Show all 11 generations
- Root · 11 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 10 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 9 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 8 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 7 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 6 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 5 generations backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- 4 generations backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 2 generations backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- 1 generation backK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- This deviceK181204 RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −10 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −9 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −8 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −7 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −6 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −5 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| −4 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 3 |
| −3 | K132446 | Renasys EZ Max Negative Pressure Wound Therapy Device | Smith & Nephew, Inc. | 2013 | — |
| −2 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits… | Smith & Nephew, Inc. | 2015 | 1 |
| −1 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K181204 | RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Summary page 6…II Product Code: OMP Predicate Device Information 510(k)# Device Clearance Date K153209 RENASYS Y-Connector August 04, 2016 (Primary Predicate) K151872… | 2016 |
| * | K151872 | Avance Y-Connector SSummary page 6…ce Clearance Date K153209 RENASYS Y-Connector August 04, 2016 (Primary Predicate) K151872 Avance Y-Connector S November 02, 2015 (Secondary Predicate) K1431… | 2015 |
| * | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Summary page 6…(Primary Predicate) K151872 Avance Y-Connector S November 02, 2015 (Secondary Predicate) K143133 RENASYS AB Abdominal July 23, 2015 Dressing Kit with Soft Port… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K153209.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
The RENASYS Y-Connector can only be used with RENASYS TOUCH and RENASYS GO systems. RENASYS TOUCH and RENASYS GO are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The following wound types may be used with a RENASYS system that is utilizing a RENASYS Y-connector: Flaps and…
Read the full statement (416 words)
The RENASYS Y-Connector can only be used with RENASYS TOUCH and RENASYS GO systems.
RENASYS TOUCH and RENASYS GO are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
The following wound types may be used with a RENASYS system that is utilizing a RENASYS Y-connector:
Flaps and grafts (only in one wound configuration)
Open abdomen (only in one wound configuration & only with RENASYS TOUCH and RENASYS AB Abdominal Kit)
Chronic
Acute
Traumatic
Sub-Acute and dehisced wounds
Ulcers (such as pressure or diabetic)
Partial-thickness burns
The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When the RENASYS Y-Connector is used with the RENASYS AB Abdominal Kit with Soft Port (only in one wound configuration), it is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
RENASYS TOUCH is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Appropriate wound types include:
Chronic
Acute
Traumatic
Sub-Acute and dehisced wounds
Ulcers (such as pressure or diabetic)
Partial-thickness burns
Flaps and grafts
The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used with the RENASYS AB Abdominal Kit with Soft Port, RENASYS TOUCH is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181204: RENASYS Y-Connector; RENASYS TOUCH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181204
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026