510(k) · Cleared
ClearedNovaspine Powered Suction Pump Pro-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novaspine, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 16, 2006 as substantially equivalent to K971548 (Kinetic Concepts, Inc., 1997) and 2 other predicates after a 54-day review. Its family tree reaches back 2 generations to 1995. 16 later devices descend from it.
- Decided
- Oct 16, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945062 (1995). 6 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 1 generation backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- This deviceK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
- Descendant · cites it directly · 15 of its ownK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK113291 Simex Negative Pressure Wound Therapy Powered Suction Pumps Series…Simex Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK141255 Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014
- Descendant · cites it directly · 3 of its ownK112853 Voltera Powered Suction PumpSuzric Enterprise Co., Ltd. · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd. · 2012 · cites it directly15descendants
- K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH · 2012 · cites it directly4descendants
- K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · 2 generations on3descendants
- K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014 · 2 generations on3descendants
- K112853Voltera Powered Suction PumpSuzric Enterprise Co., Ltd. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −1 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
| +1 | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200… | Simex Medizintechnik GmbH | 2012 | — |
| +2 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | 2017 | — |
| +2 | K141255 | Simex Subglottic Aspiration System | Simex Medizintechnik GmbH | 2014 | — |
| +1 | K112853 | Voltera Powered Suction Pump | Suzric Enterprise Co., Ltd. | 2012 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K971548 | AmbuvacSummary page 1…t Code BTA - Pump, Portable, Aspiration, (Manual or Powered) Substantial Equivalency Kinetic Concepts K971548 "AmbuVAC" Blue Sky Medical Group, Inc. K042 134… | 1997 |
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…tial Equivalency Kinetic Concepts K971548 "AmbuVAC" Blue Sky Medical Group, Inc. K042 134 "Versatile 1 Wound Vacuum System" NovaSpine LLC K061 13… | 2004 |
| * | K061133 | Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SSummary page 1…Blue Sky Medical Group, Inc. K042 134 "Versatile 1 Wound Vacuum System" NovaSpine LLC K061 133 "SHIMEX Suction Pump" Indications for Use The NovaSpine Powered Suction Pu… | 2006 |
What descends from it? (16)
See all 163 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 11 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K112458 (Medica-Rents Co., Ltd., 2012) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K971548.
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.
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 NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062456: Novaspine Powered Suction Pump Pro-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062456
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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