510(k) · Cleared
ClearedMedone Ultra, Medextra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medax Srl Unipersonale · KNW Instrument, Biopsy
Cleared on Apr 2, 2020 as substantially equivalent to K141552 (Care Fusion, 2014) and 1 other predicate after a 241-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Apr 2, 2020
- Review
- 241 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922939 (1993). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
- 2 generations backK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
- 1 generation backK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
- This deviceK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
- Descendant · cites it directly · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922939 | Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. | C.R. Bard, Inc. | 1993 | — |
| −2 | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)… | Bard Peripheral Vascular, Inc. | 2014 | 7 |
| −1 | K141552 | Achieve Programmable Auomated Biopsy Systems | Care Fusion | 2014 | — |
| 0 (this device) | K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020 | — |
| +1 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 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? (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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed… | 2021 | 1 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K210946 (Promisemed Hangzhou Meditech Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K141552.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy.
MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192101: Medone Ultra, Medextra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192101
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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