510(k) · Cleared
ClearedSIRA RFA Electrosurgical Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innoblative Designs, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 16, 2019 as substantially equivalent to K073495 (Tissuelink Medical, Inc., 2008) after a 268-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jan 16, 2019
- Review
- 268 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954171 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 4 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 3 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 2 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- 1 generation backK073495 Tissuelink Aquamantys Malleable Bipolar Sealer with LightTissuelink Medical, Inc. · 2008
- This deviceK181071 SIRA RFA Electrosurgical DeviceInnoblative Designs, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232947 SIRA™ RFA Electrosurgical DeviceInnoblative Designs, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232947SIRA™ RFA Electrosurgical DeviceInnoblative Designs, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −4 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −3 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −2 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| −1 | K073495 | Tissuelink Aquamantys Malleable Bipolar Sealer with Light | Tissuelink Medical, Inc. | 2008 | — |
| 0 (this device) | K181071 | SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. | 2019 | — |
| +1 | K232947 | SIRA™ RFA Electrosurgical Device | Innoblative Designs, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K073495 | Tissuelink Aquamantys Malleable Bipolar Sealer with LightSummary page 4…rosurgical Device Classification 21 CFR 878.4400, Class II, product code GEI Predicate Device Medtronic Aquamantys Malleable Bipolar Sealer with Light (K073495) Intended Use / Indications for Use The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and i… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232947 | SIRA™ RFA Electrosurgical Device | 2023 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K232947 (Innoblative Designs, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coagulation and ablation of soft tissue. The SIRA™ RFA Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181071: SIRA RFA Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181071
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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