510(k) · Cleared
ClearedEmg Suction Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emg Technology Co., Ltd. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Sep 1, 2011 as substantially equivalent to K041199 (Thomas Industries, 2004) after a 9-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 1, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944399 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944399 Medi-PumpThomas Industries · 1995
- 1 generation backK041199 Medi-Pump Aspirator, Model 1615Thomas Industries · 2004
- This deviceK112421 Emg Suction UnitEmg Technology Co., Ltd. · 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
- Descendant · cites it directly · 0 of its ownK140031 Suction PumpDing Hwa Co., Ltd. · 2014
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 |
|---|---|---|---|---|---|
| −2 | K944399 | Medi-Pump | Thomas Industries | 1995 | — |
| −1 | K041199 | Medi-Pump Aspirator, Model 1615 | Thomas Industries | 2004 | — |
| 0 (this device) | K112421 | Emg Suction Unit | Emg Technology Co., Ltd. | 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 | — |
| +1 | K140031 | Suction Pump | Ding Hwa Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041199 | Medi-Pump Aspirator, Model 1615Summary page 1…21 CFR 878.4780 Product Code: JOX Classification Panel: General & Plastic Surgery 3. Information of the 510(k) Cleared Device(Predicate Device): 51 0(k) Number : K041199 Device Name: Medi-Pump Aspirator, Model 1615 Applicant: Thom as IndustriesPaeIo 4… | 2004 |
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 16 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182950 (Acare Technology Co., Ltd., 2019) has gone furthest, with 1 descendant 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. 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 intended to be used to remove body fluids from a patient's airway or respiratory system. It is for use on the order of a physician only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112421: Emg Suction Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112421
Report an extraction error
Are you the manufacturer?
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