510(k) · Cleared
ClearedAchieve Programmable Auomated Biopsy Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · KNW Instrument, Biopsy
Cleared on Sep 5, 2014 as substantially equivalent to K960064 (Bauer Medical, Inc., 1996) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1993. 11 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922939 (1993). 3 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
- 1 generation backK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
- This deviceK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
- Descendant · cites it directly · 4 of its ownK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
- Descendant · 2 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241793 Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy…Zhejiang Curaway Medical Technology Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · cites it directly4descendants
- K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020 · cites it directly2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 3 generations on0descendants
- K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922939 | Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. | C.R. Bard, Inc. | 1993 | — |
| −1 | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)… | Bard Peripheral Vascular, Inc. | 2014 | 7 |
| 0 (this device) | K141552 | Achieve Programmable Auomated Biopsy Systems | Care Fusion | 2014 | — |
| +1 | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… | M.D.L. S.R.L. | 2016 | 1 |
| +1 | K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020 | — |
| +2 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +3 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
| +1 | K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/… | Zhejiang Curaway Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K960064 | Temno Achieve Biopsy NeedleSummary page 4…stroenterology/Urology Regulation Class II per 21CFR §876.1075 Product Code(s) KNW Legally marketed device(s) K960064 CareFusion Achieve (Formerly Bauer Medical) to which equivalence is and K133948 Bard Monopty claimed… | 1996 |
| * | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Summary page 4…KNW Legally marketed device(s) K960064 CareFusion Achieve (Formerly Bauer Medical) to which equivalence is and K133948 Bard Monopty claimed Reason for 510(k) Updates to labeling and device modifications. submission… | 2014 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium… | 2016 | 4 |
| K192101 | Medone Ultra, Medextra | 2020 | 2 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable… | 2025 | 0 |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System | 2024 | 0 |
| K191472 | Biopsy Needle | 2020 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K160316 (M.D.L. S.R.L., 2016) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K960064.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone. The Achieve Programmable Automatic Biopsy System 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…
Read the full statement (132 words)
Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.
The Achieve Programmable Automatic Biopsy System 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141552: Achieve Programmable Auomated Biopsy Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141552
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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