510(k) · Cleared
ClearedEuromi Eva SP6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euromi S.A · QPB System, Suction, Lipoplasty For Removal
Cleared on Dec 16, 2010 as substantially equivalent to K981215 (Byron Medical, 1998) and 1 other predicate after a 210-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 16, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895761 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −2 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −1 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| 0 (this device) | K101413 | Euromi Eva SP6 | Euromi S.A | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K981215 | Psi-Tec Liposuction AspiratorSummary page 5…m " Liposuction Suction System Classification: Class 11,21 CFR 878.5040, MUU Predicate Device [21 CFR 807.92(a)(3)] Byron Medical, PSI-Tec Liposuction, K981215 Byron Medical, PSI-Tec Infiltration Pump, K040149 Description of the Device [21 CFR 807.92(a)(4)] The subject device is used in… | 1998 |
| * | K040149 | Psi-Tec Peristaltic Infiltration PumpSummary page 5…assification: Class 11,21 CFR 878.5040, MUU Predicate Device [21 CFR 807.92(a)(3)] Byron Medical, PSI-Tec Liposuction, K981215 Byron Medical, PSI-Tec Infiltration Pump, K040149 Description of the Device [21 CFR 807.92(a)(4)] The subject device is used in conjunction with the Lipomnatic Handpiece. The Li… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K981215.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The device is intended to be used for aesthetic body contouring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101413: Euromi Eva SP6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101413
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