510(k) · Cleared
ClearedVacplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Mar 14, 1995 after a 151-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 220 devices in its family, counting itself, has a Class I recall. 219 later devices descend from it.
- Decided
- Mar 14, 1995
- Review
- 151 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 0
219 later devices descend from it, 4 citing it directly. 1 of the 220 devices in this family, counting this one, has a Class I recall.
- This deviceK945062 VacplusKinetic Concepts, Inc. · 1995
- Descendant · cites it directly · 159 of its ownK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- Descendant · cites it directly · 156 of its ownK971548 AmbuvacKinetic Concepts, Inc. · 1997
- Descendant · cites it directly · 150 of its ownK992448 V.a.C. PlusKinetic Concepts, Inc. · 2000
- Descendant · 2 generations on · 127 of its ownK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- Descendant · 2 generations on · 120 of its ownK061435 Medela Vario Suction PumpsMedela AG · 2006
Showing 5 of 219 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVES3 generations on · 2010
Most influential descendants
Showing 5 of 219 · See all- K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · cites it directly159descendants
- K971548AmbuvacKinetic Concepts, Inc. · 1997 · cites it directly156descendants
- K992448V.a.C. PlusKinetic Concepts, Inc. · 2000 · cites it directly150descendants
- K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005 · 2 generations on127descendants
- K061435Medela Vario Suction PumpsMedela AG · 2006 · 2 generations on120descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| +1 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| +1 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| +1 | K992448 | V.a.C. Plus | Kinetic Concepts, Inc. | 2000 | — |
| +2 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| +2 | K061435 | Medela Vario Suction Pumps | Medela AG | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 8 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 1 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 8 | 0 |
| 2014 | 13 | 0 |
| 2015 | 18 | 0 |
| 2016 | 22 | 0 |
| 2017 | 13 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (219)
See all 2194 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K042134 (Blue Sky Medical Group Incorporated, 2004) has gone furthest, with 159 descendants of its own.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 0 | — | 0 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K945062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945062: Vacplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945062
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026