510(k) · Cleared
ClearedVT - 100, VT - 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carilex Medical, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Aug 9, 2018 as substantially equivalent to K112853 (Suzric Enterprise Co., Ltd., 2012) after a 281-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Aug 9, 2018
- Review
- 281 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945062 (1995). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 3 generations backK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
- 2 generations backK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
- 1 generation backK112853 Voltera Powered Suction PumpSuzric Enterprise Co., Ltd. · 2012
- This deviceK173407 VT - 100, VT - 200Carilex Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK231646 Carilex VT¿200-i NXCarilex Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231646Carilex VT¿200-i NXCarilex Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −4 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −3 | K062456 | Novaspine Powered Suction Pump Pro-1 | Novaspine, LLC | 2006 | — |
| −2 | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System | Medica-Rents Co., Ltd. | 2012 | — |
| −1 | K112853 | Voltera Powered Suction Pump | Suzric Enterprise Co., Ltd. | 2012 | — |
| 0 (this device) | K173407 | VT - 100, VT - 200 | Carilex Medical, Inc. | 2018 | — |
| +1 | K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K112853 | Voltera Powered Suction PumpSummary page 4…: OMP Panel: General & Plastic Surgery 5. Predicate Device Information: VOLTERA Powered Suction Pump, S1001-3 Series, K112853 6. Device Description Carilex VT‧100 and VT‧200 are suction pumps with collection canisters for negative pressure wo… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231646 | Carilex VT¿200-i NX | 2024 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K231646 (Carilex Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112853.
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. 2018, 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?
Carilex VT - 100/VT - 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing.
The VT + 100/VT - 200 suction therapy unit is indicated on use with patients with the following wounds:
© Traumatic
® Dehisced wounds
e Partial-thickness burns
e Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
e Acute wounds
e Flaps and grafts
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/K173407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173407: VT - 100, VT - 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173407
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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