510(k) · Cleared
ClearedMedsol Goldenberg Bone Marrow Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsol Corp. · KNW Instrument, Biopsy
Cleared on Dec 10, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK983187 Medsol Goldenberg Bone Marrow Biopsy NeedleMedsol Corp. · 1998
- Descendant · cites it directly · 14 of its ownK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
- Descendant · 3 generations on · 4 of its ownK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
- Descendant · 2 generations on · 4 of its ownK071732 MarrowminerStemcor Systems, Inc. · 2007
- Descendant · 3 generations on · 3 of its ownK152474 Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005 · cites it directly14descendants
- K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007 · 2 generations on7descendants
- K081713Vertebral Access System by VidacareVidacare Corporation · 2008 · 3 generations on4descendants
- K071732MarrowminerStemcor Systems, Inc. · 2007 · 2 generations on4descendants
- K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983187 | Medsol Goldenberg Bone Marrow Biopsy Needle | Medsol Corp. | 1998 | — |
| +1 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| +2 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
| +3 | K081713 | Vertebral Access System by Vidacare | Vidacare Corporation | 2008 | — |
| +2 | K071732 | Marrowminer | Stemcor Systems, Inc. | 2007 | — |
| +3 | K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K043523 (Medical Device Technologies, Inc., 2005) has gone furthest, with 14 descendants 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.
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?
Far procuring bone marrow care biopsies
from patients with hamatologic anomalities
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983187: Medsol Goldenberg Bone Marrow Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983187
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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