510(k) · Cleared
ClearedSchuco-Vac Model 178
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schuco, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Apr 5, 1994 after a 161-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 28 later devices descend from it.
- Decided
- Apr 5, 1994
- Review
- 161 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- Descendant · cites it directly · 26 of its ownK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 16 of its ownK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- Descendant · 2 generations on · 15 of its ownK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- Descendant · 2 generations on · 13 of its ownK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- Descendant · 3 generations on · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K982304Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · cites it directly26descendants
- K063448Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006 · 2 generations on16descendants
- K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008 · 2 generations on15descendants
- K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010 · 2 generations on13descendants
- K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| +1 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| +2 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| +2 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| +2 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| +3 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (28)
See all 282 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?
- Of its descendants, K982304 (Sunrise Medical Hhg, Inc., 1998) has gone furthest, with 26 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/K935218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935218: Schuco-Vac Model 178.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935218
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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