510(k) · Cleared
ClearedSurBlate Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mima-Pro Scientific, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Feb 28, 2023 as substantially equivalent to K083157 (H.S Hospital Service S.P.A, 2009) after a 127-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Feb 28, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K861904 (1986). 28 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 6 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 5 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 4 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 1 generation backK083157 HS AmicaH.S Hospital Service S.P.A · 2009
- This deviceK223272 SurBlate Ablation SystemMima-Pro Scientific, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −5 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −4 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −1 | K083157 | HS Amica | H.S Hospital Service S.P.A | 2009 | — |
| 0 (this device) | K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 NEY? 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 NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 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 |
|---|---|---|---|
| * | K083157 | HS AmicaSummary page 4…0k Review Panel: General and Plastic Surgery III. PREDICATE DEVICE Predicate Manufacturer: H.S. Hospital Service S.p.A. Predicate Trade Name: HS AMICA Predicate 510(k): K083157 This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The SurBlate™ Ablation System is an integ… | 2009 |
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 37 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 5 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K083157.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, 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 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SurBlate™ Ablation System is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223272: SurBlate Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223272
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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