510(k) · Cleared
ClearedNeoNavia Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neodynamics AB · KNW Instrument, Biopsy
Cleared on Sep 8, 2022 as substantially equivalent to K153709 (Devicor Medical Products, Inc., 2016) after a 191-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Sep 8, 2022
- Review
- 191 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K062832 (2006). 8 ancestors in all, the oldest K003297 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · Recalled
- 3 generations backK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
- 2 generations backK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
- 1 generation backK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
- This deviceK220595 NeoNavia Biopsy SystemNeodynamics AB · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138 | C.R. Bard, Inc. | 2006 | 1 |
| −4 | K082681 | Vacora Vacuum Assisted Biopsy System | C.R. Bard, Inc. | 2008 | 4 |
| −3 | K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk… | C.R. Bard, Inc. | 2009 | — |
| −2 | K112411 | Mammotome Elite Biopsy System | Devicor Medical Products, Inc. | 2012 | — |
| −1 | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G… | Devicor Medical Products, Inc. | 2016 | — |
| 0 (this device) | K220595 | NeoNavia Biopsy System | Neodynamics AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 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 KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 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 |
|---|---|---|---|
| * | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Summary page 4…rimary Device Trade Name: Mammotome elite® Biopsy System Device Company: Devicor® Medical Products, Inc. 510(k) Number: K153709 Device Description : NeoNavia® biopsy system is designed to obtain tissue samples from breast lesions or axillary lymph nodes f… | 2016 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K153709.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes
for diagnostic analysis of breast abnormalities.
The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for
histologic examination.
The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220595: NeoNavia Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220595
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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