510(k) · Cleared
ClearedMarrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopsybell S.R.L. · KNW Instrument, Biopsy
Cleared on Jan 11, 2021 as substantially equivalent to K150563 (Ranfac, Corp., 2015) and 1 other predicate after a 54-day review. Its family tree reaches back 9 generations to 1987. 1 of the 37 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 11, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K871390 (1987). 36 ancestors in all. No later device cites it as a predicate yet. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 5 generations between
- 3 generations backK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- 2 generations backK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
- 1 generation backK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
- This deviceK203397 Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray…Biopsybell S.R.L. · 2021
Show all 9 generations
- Root · 9 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 8 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 7 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 6 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 5 generations backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- 4 generations backK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- 3 generations backK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- 2 generations backK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
- 1 generation backK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
- This deviceK203397 Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray…Biopsybell S.R.L. · 2021
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow4 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −8 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −7 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −6 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −5 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| −4 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| −3 | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
| −2 | K140991 | Ranfac Aspiration Needle with Adjustable Guide | Ranfac, Corp. | 2014 | — |
| −1 | K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015 | — |
| 0 (this device) | K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)-… | Biopsybell S.R.L. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 1 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150563 | Marrow Cellution Bone Marrow Aspiration NeedleSummary page 4…: Applicant Device name 510(k) Number RANFAC Marrow Cellution Bone Marrow K150563 Aspiration Needle BIOPSYBELL Manual-bone-marrow-biopsy-needles, Semi-… | 2015 |
| * | K130616 | Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesSummary page 4…one Marrow K150563 Aspiration Needle BIOPSYBELL Manual-bone-marrow-biopsy-needles, Semi- K130616 automatic-biopsy-needles, Automatic-biopsy-needles PAGE. ϭOF ϰ ==… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 36 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K150563.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203397: Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203397
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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