510(k) · Cleared
ClearedCASSI II Rotational Core Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scion Medical Technologies, LLC · KNW Instrument, Biopsy
Cleared on Aug 3, 2016 as substantially equivalent to K123606 (Scion Medical Technologies, LLC, 2013) after a 93-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 3, 2016
- Review
- 93 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003528 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
- 6 generations backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
- 5 generations backK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
- 4 generations backK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
- 3 generations backK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
- 2 generations backK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
- 1 generation backK123606 Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableScion Medical Technologies, LLC · 2013
- This deviceK161234 CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003528 | Sanarus Core Tissue Biopsy System | Endocare, Inc. | 2001 | — |
| −6 | K021137 | Sanarus Centrica Core Tissue Biopsy System | Sanarus Medical, Inc. | 2002 | — |
| −5 | K022879 | Modification to Sanarus Centrica Core Tissue Biopsy | Sanarus Medical, Inc. | 2002 | 1 |
| −4 | K032506 | Sanarus Centrica II Rotational Core Biopsy System | Sanarus Medical, Inc. | 2003 | — |
| −3 | K042136 | Sanarus Cassi Rotational Core Biopsy System | Sanarus Medical, Inc. | 2004 | — |
| −2 | K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 | Sanarus Medical, Inc. | 2005 | — |
| −1 | K123606 | Cassi II Rotational Core Biopsy System; Cassi Quadpoint Disposable | Scion Medical Technologies, LLC | 2013 | — |
| 0 (this device) | K161234 | CASSI II Rotational Core Biopsy System | Scion Medical Technologies, LLC | 2016 | — |
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 |
|---|---|---|---|
| * | K123606 | Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableSummary page 4…e: KNW Classification panel: Gastroenterology-urology C) Predicate: CASSI II Rotational Core Biopsy System, with the CASSI QuadPoint Disposable K123606 Cleared on March 1st, 2013 D) Date Prepared: April 28, 2016 E) Device Description The proposed CASSI II Rotational Cor… | 2013 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Cassi Rotational Core Biopsy 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 Cassi Device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged…
Read the full statement (137 words)
The Cassi Rotational Core Biopsy 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 Cassi Device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of a histological 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 histological 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161234: CASSI II Rotational Core Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161234
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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