510(k) · Cleared
ClearedMED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
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 K181803 (Medax Srl Unipersonale, 2018) and 2 other predicates after a 241-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Apr 2, 2020
- Review
- 241 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K890925 (1989). 20 ancestors in all, the oldest K813338 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 4 generations backK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- 3 generations backK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- 2 generations backK070091 Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007
- 1 generation backK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017 · Recalled
- This deviceK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −4 | K990515 | Mathis Vertebral and Bone Biopsy System | International Medical Systems | 1999 | — |
| −3 | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| −2 | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007 | — |
| −1 | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow… | Care Fusion | 2017 | 6 |
| 0 (this device) | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle… | Medax Srl Unipersonale | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K181803 | Medax Biopsy Systems IIISummary page 6…and Aspiration Systems Device MED-I HANDLEX MEDAX S.R.L. K181803 - Medax Bone Bone marrow UNIPERSONALE Biopsy System marrow… | 2018 |
| * | K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Summary page 6…FDA on needle 10/18/2018 MED-L MEDLOCK MEDAX S.R.L. K172344 - Medax Bone Bone marrow UNIPERSONALE Biopsy System II, marrow biops… | 2017 |
| * | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Summary page 6…on 11/13/2017 aspiration system BD/Carefusion, Carefusion K171531 - MED-J Original Jamshidi Bone… | 2017 |
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 31 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 6 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181803.
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?
MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum. MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest. MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest…
Read the full statement (131 words)
MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum.
MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest.
MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192099 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192099: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192099
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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