510(k) · Cleared
ClearedVacplus Suction Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Medical Corp. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Feb 24, 2011 as substantially equivalent to K982304 (Sunrise Medical Hhg, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 24, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935218 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 1 generation backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- This deviceK103535 Vacplus Suction UnitApex Medical Corp. · 2011
- Descendant · cites it directly · 1 of its ownK182950 Acare Suction UnitAcare Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK250964 Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −1 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| 0 (this device) | K103535 | Vacplus Suction Unit | Apex Medical Corp. | 2011 | — |
| +1 | K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | 2019 | — |
| +2 | K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 JCX? 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? (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 |
|---|---|---|---|
| * | K982304 | Devilbiss Suction UnitSummary page 1…Powered Suction Pump (FDA 21 CFR 878.4780 Class 11) 8. Device Product Code: JCX 9. Predicate Device: DeVilbiss Suction Unit, Model 7305P FDA 5 10(k) number: K982304 I 0.Device Description: Vaclus is the portable AC/DC powered suction unit. Each one consists of an on/off switch, a pump… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182950 | Acare Suction Unit | 2019 | 1 |
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 3 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182950 (Acare Technology Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K982304.
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. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The device is to be used to remove fluids from the treated tracheotomy patient airway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103535: Vacplus Suction Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103535
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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