510(k) · Cleared
ClearedINUMI™ Flex Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galvanize Therapeutics, Inc. · OAB Low Energy Direct Current Thermal Ablation System
Cleared on May 22, 2024 as substantially equivalent to K212871 (Galvanize Therapeutics, Inc., 2022) after a 166-day review. Its family tree reaches back 13 generations to 1995. 1 later device descends from it.
- Decided
- May 22, 2024
- Review
- 166 days
- Class
- Class II
- Product code
- OAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K942299 (1995). 51 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 9 generations between
- 3 generations backK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
- 2 generations backK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled
- 1 generation backK212871 Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya…Galvanize Therapeutics, Inc. · 2022
- This deviceK233884 INUMI™ Flex NeedleGalvanize Therapeutics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253826 Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya®…Galvanize Therapeutics, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 12 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 11 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 10 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 9 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 8 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 7 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 6 generations backK060054 Oncobionic SystemOncobionics, Inc. · 2006
- 5 generations backK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
- 4 generations backK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
- 3 generations backK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
- 2 generations backK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled
- 1 generation backK212871 Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya…Galvanize Therapeutics, Inc. · 2022
- This deviceK233884 INUMI™ Flex NeedleGalvanize Therapeutics, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −12 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −11 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −10 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −9 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −8 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −7 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −6 | K060054 | Oncobionic System | Oncobionics, Inc. | 2006 | — |
| −5 | K080376 | Oncobionic System | Oncobionic Incorporated | 2008 | 1 |
| −4 | K102329 | Nanoknife System | AngioDynamics, Inc. | 2011 | 1 |
| −3 | K150089 | NanoKnife System | AngioDynamics, Inc. | 2015 | 1 |
| −2 | K183385 | NanoKnife System | Angiodynamics | 2019 | 1 |
| −1 | K212871 | Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode | Galvanize Therapeutics, Inc. | 2022 | — |
| 0 (this device) | K233884 | INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | 2024 | — |
| +1 | K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™… | Galvanize Therapeutics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OAB? 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 OAB device
- #1 K253826 Aliya® EX System; Aliya® EX Generator; Aliya®…score 15.2 · 14 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 |
|---|---|---|---|
| * | K212871 | Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeSummary page 4…system Review Panel: General & Plastic Surgery (SU) Primary Predicate Device Device Trade Name: Aliya™ System 510(k) Number K212871 Manufacturer: Galvanize Therapeutics Device Description The INUMI™ Flex Needle (subject device) is an endoscopi… | 2022 |
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 |
|---|---|---|---|
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle | 2026 | 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 29 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 51 ancestors have a recall of any class.
- Of its descendants, K253826 (Galvanize Therapeutics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212871.
How does its category compare?
All OAB devicesOAB Low Energy Direct Current Thermal Ablation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OAB
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OAB
129in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAB
10in 2025
MAUDE reports naming product code OAB, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 16 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 4 | 129 | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.
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/K233884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233884: INUMI™ Flex Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233884
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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