510(k) · Cleared
ClearedAntlia Iii Wound Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Therapies, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Aug 8, 2011 as substantially equivalent to K070904 (Innovative Therapies, Inc., 2007) after an 88-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 8, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945062 (1995). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 2 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 1 generation backK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- This deviceK111333 Antlia Iii Wound Treatment SystemInnovative Therapies, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK143016 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal…Cardinalhealth · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK150124 Cardinal Health NPWT PRO HCCardinalhealth · 2015
- Descendant · 3 generations on · 1 of its ownK161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT…Cardinalhealth · 2017
- Descendant · 4 generations on · 0 of its ownK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK171499 Occlusion Detection Dressing KitCardinalhealth · 2017
Most influential descendants
Showing 5 of 5 · See all- K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth · 2015 · cites it directly4descendants
- K150124Cardinal Health NPWT PRO HCCardinalhealth · 2015 · 2 generations on3descendants
- K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetCardinalhealth · 2017 · 3 generations on1descendant
- K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026 · 4 generations on0descendants
- K171499Occlusion Detection Dressing KitCardinalhealth · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −2 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −1 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| 0 (this device) | K111333 | Antlia Iii Wound Treatment System | Innovative Therapies, Inc. | 2011 | — |
| +1 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT… | Cardinalhealth | 2015 | 2 |
| +2 | K150124 | Cardinal Health NPWT PRO HC | Cardinalhealth | 2015 | — |
| +3 | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation… | Cardinalhealth | 2017 | — |
| +4 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026 | — |
| +3 | K171499 | Occlusion Detection Dressing Kit | Cardinalhealth | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K070904 | Antlia II Suction Pump SystemSummary page 1…Class 11; Product Code: OMP 5. Predicate Device: Antlia IITM Suction Pump System 5 10(k) No.K070904 6. Description of Device The Antlia 11P~M Wound Treatment System is an AC-powered, portable suction d… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | 2015 | 4 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K143016 (Cardinalhealth, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K070904.
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. 2011, 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 Antlia IIITM Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.
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/K111333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111333: Antlia Iii Wound Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111333
Report an extraction error
Are you the manufacturer?
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