510(k) · Cleared
ClearedSanarus Core Tissue Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocare, Inc. · KNW Instrument, Biopsy
Cleared on May 3, 2001 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 168 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
- Descendant · 2 generations on · 10 of its ownK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 9 of its ownK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
- Descendant · 4 generations on · 8 of its ownK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
- Descendant · 5 generations on · 4 of its ownK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K021137Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002 · cites it directly11descendants
- K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · 2 generations on10descendants
- K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003 · 3 generations on9descendants
- K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004 · 4 generations on8descendants
- K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003528 | Sanarus Core Tissue Biopsy System | Endocare, Inc. | 2001 | — |
| +1 | K021137 | Sanarus Centrica Core Tissue Biopsy System | Sanarus Medical, Inc. | 2002 | — |
| +2 | K022879 | Modification to Sanarus Centrica Core Tissue Biopsy | Sanarus Medical, Inc. | 2002 | 1 |
| +3 | K032506 | Sanarus Centrica II Rotational Core Biopsy System | Sanarus Medical, Inc. | 2003 | — |
| +4 | K042136 | Sanarus Cassi Rotational Core Biopsy System | Sanarus Medical, Inc. | 2004 | — |
| +5 | K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 | Sanarus Medical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 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, K021137 (Sanarus Medical, Inc., 2002) has gone furthest, with 11 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) | — |
https://510kreport.com/device/K003528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003528: Sanarus Core Tissue Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003528
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026