510(k) · Cleared
ClearedMedax Unipersonale SRL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medax Unipersonale Srl · KNW Instrument, Biopsy
Cleared on May 27, 2011 after a 661-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- May 27, 2011
- Review
- 661 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK092338 Medax Unipersonale SRLMedax Unipersonale Srl · 2011
- Descendant · cites it directly · 1 of its ownK172344 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 2017
- Descendant · 2 generations on · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
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 |
|---|---|---|---|---|---|
| 0 (this device) | K092338 | Medax Unipersonale SRL | Medax Unipersonale Srl | 2011 | — |
| +1 | K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | Medax Srl Unipersonale | 2017 | — |
| +2 | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle… | Medax Srl Unipersonale | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | 2017 | 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?
- Of its descendants, K172344 (Medax Srl Unipersonale, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Device name: Universal Duo. Intended use: to be used for histological biopsy on soft tissues. Device name: Neoxus. Intended use: to retrieve bone marrow and bone samples from iliac crest. Device name: Cage. Intended use: to retrieve bone marrow and bone samples from iliac crest. Device name: Velox. Intended use: histological biopsy on soft tissues Device name: Velox 2. Intended use: histolegical biopsy on soft tissues Device name: Universal Plus.…
Read the full statement (184 words)
Device name: Universal Duo. Intended use: to be used for histological biopsy on soft tissues.
Device name: Neoxus. Intended use: to retrieve bone marrow and bone samples from iliac crest.
Device name: Cage. Intended use: to retrieve bone marrow and bone samples from iliac crest.
Device name: Velox. Intended use: histological biopsy on soft tissues
Device name: Velox 2. Intended use: histolegical biopsy on soft tissues
Device name: Universal Plus. Intended use: histological biopsy on soft tissues.
Device name: Universal. Intended use: histological biopsy on soft tissues.
Device name: Perfectus. Intended use: aspiration bone marrow from sternum or iliac crest.
Device name: Lux. Intended use: histological biopsy on soft tissues
Device name: Lux 2. Intended use: histological biopsy on soft tissues
Device name: Hepax. Intended use: histological and cytological biopsies of soft tissue
Device name: FNA (Chiba /Quincke /Turner/ Westcott / Franseen). Intended use: Aspiration needle for cyto - histological biopsies on soft tissue.
Device name: Facile. Intended use: histological biopsy on soft tissues
Device name: Cesar. Intended use: histological biopsy on soft tissues
Device name: Nextage. Intended use: histological biopsy on soft tissues
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/K092338 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092338: Medax Unipersonale SRL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092338
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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