510(k) · Cleared
ClearedVoltera Powered Suction Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzric Enterprise Co., Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Nov 9, 2012 as substantially equivalent to K062456 (Novaspine, LLC, 2006) and 1 other predicate after a 407-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 9, 2012
- Review
- 407 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945062 (1995). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 2 generations backK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
- 1 generation backK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
- This deviceK112853 Voltera Powered Suction PumpSuzric Enterprise Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK173407 VT - 100, VT - 200Carilex Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK231646 Carilex VT¿200-i NXCarilex Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK161410 VT·One, VT·One 60daysCarilex Medical, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView 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 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −2 | K062456 | Novaspine Powered Suction Pump Pro-1 | Novaspine, LLC | 2006 | — |
| −1 | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System | Medica-Rents Co., Ltd. | 2012 | — |
| 0 (this device) | K112853 | Voltera Powered Suction Pump | Suzric Enterprise Co., Ltd. | 2012 | — |
| +1 | K173407 | VT - 100, VT - 200 | Carilex Medical, Inc. | 2018 | — |
| +2 | K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024 | — |
| +1 | K161410 | VT·One, VT·One 60days | Carilex Medical, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K062456 | Novaspine Powered Suction Pump Pro-1Summary page 1…: NovaSpine Powered Suction Pump PRO-I Manufacturer: NovaSpine LLC 510(k) Number or Clearance Information: K062456 Predicate Device Name: Prospera PRO-I, PRO-Il and PRO-Ill Negative… | 2006 |
| * | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System Cleared while this submission was under review Summary page 3…S 1001-3 Series) K062456) Wound Therapy System, K112458) Classification Class 11 Class 11 Class 1I Code or Federal 878.4780… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K173407 (Carilex Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K062456.
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. 2012, 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 VOLTERA Powered Suction Pump, S1001-3 Series 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 VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112853: Voltera Powered Suction Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112853
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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