510(k) · Cleared
Recalled · 2003Modification to Sanarus Centrica Core Tissue Biopsy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanarus Medical, Inc. · KNW Instrument, Biopsy
Cleared on Sep 23, 2002 as substantially equivalent to K021137 (Sanarus Medical, Inc., 2002) after a 24-day review. Its family tree reaches back 2 generations to 2001. 10 later devices descend from it. It has been recalled once.
- Decided
- Sep 23, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003528 (2001). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
- 1 generation backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
- This deviceK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
- Descendant · 3 generations on · 4 of its ownK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
- Descendant · 4 generations on · 1 of its ownK123606 Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableScion Medical Technologies, LLC · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003 · cites it directly9descendants
- K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004 · 2 generations on8descendants
- K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005 · 3 generations on4descendants
- K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005 · 3 generations on3descendants
- K123606Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableScion Medical Technologies, LLC · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003528 | Sanarus Core Tissue Biopsy System | Endocare, Inc. | 2001 | — |
| −1 | K021137 | Sanarus Centrica Core Tissue Biopsy System | Sanarus Medical, Inc. | 2002 | — |
| 0 (this device) | K022879 | Modification to Sanarus Centrica Core Tissue Biopsy | Sanarus Medical, Inc. | 2002 | — |
| +1 | K032506 | Sanarus Centrica II Rotational Core Biopsy System | Sanarus Medical, Inc. | 2003 | — |
| +2 | K042136 | Sanarus Cassi Rotational Core Biopsy System | Sanarus Medical, Inc. | 2004 | — |
| +3 | K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 | Sanarus Medical, Inc. | 2005 | — |
| +3 | K053151 | Rubicor Magic Breast Biopsy Device | Rubicor Medical, Inc. | 2005 | — |
| +4 | K123606 | Cassi II Rotational Core Biopsy System; Cassi Quadpoint Disposable | Scion Medical Technologies, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K021137 | Sanarus Centrica Core Tissue Biopsy System | 2002 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032506 | Sanarus Centrica II Rotational Core Biopsy System | 2003 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2003 | Not classified | Z-0935-03 | Other | Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032506 (Sanarus Medical, Inc., 2003) has gone furthest, with 9 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?
The device is indicated for use in obtaining biopsies from soft tissues such as' liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic…
Read the full statement (131 words)
The device is indicated for use in obtaining biopsies from soft tissues such as' liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022879: Modification to Sanarus Centrica Core Tissue Biopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022879
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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