510(k) · Cleared
Recalled · Class II · 2021SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.D.L. S.R.L. · KNW Instrument, Biopsy
Cleared on Oct 27, 2016 as substantially equivalent to K934371 (Bip USA, Inc., 1994) and 3 other predicates after a 265-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 27, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K922939 (1993). 6 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
- 2 generations backK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
- 1 generation backK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
- This deviceK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016
- Descendant · cites it directly · 0 of its ownK212820 Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2022
- Descendant · cites it directly · 0 of its ownK212822 Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation · 2022
- Descendant · cites it directly · 0 of its ownK212819 Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation · 2022
- Descendant · cites it directly · 0 of its ownK214063 Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy…Guangzhou Shengwei Medical Devices Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2022 · cites it directly0descendants
- K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation · 2022 · cites it directly0descendants
- K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation · 2022 · cites it directly0descendants
- K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922939 | Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. | C.R. Bard, Inc. | 1993 | — |
| −2 | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)… | Bard Peripheral Vascular, Inc. | 2014 | 7 |
| −1 | K141552 | Achieve Programmable Auomated Biopsy Systems | Care Fusion | 2014 | — |
| 0 (this device) | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… | M.D.L. S.R.L. | 2016 | — |
| +1 | K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2022 | — |
| +1 | K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022 | — |
| +1 | K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022 | — |
| +1 | K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and… | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K934371 | Bip Multi ModificationSummary page 5…FCG Predicate Devices: 510k Number Bard® MAGNUM® Reusable Core Biopsy Instrument K934371 Carefusion Temno Semi-Automatic Disposable Biopsy Instrument K960064 Carefusion Achieve Automatic Biopsy System… | 1994 |
| * | K960064 | Temno Achieve Biopsy NeedleSummary page 5…Number Bard® MAGNUM® Reusable Core Biopsy Instrument K934371 Carefusion Temno Semi-Automatic Disposable Biopsy Instrument K960064 Carefusion Achieve Automatic Biopsy System K141552 H.S. Hospital Service Biomol Aspiration Bi… | 1996 |
| * | K141552 | Achieve Programmable Auomated Biopsy SystemsSummary page 5…K934371 Carefusion Temno Semi-Automatic Disposable Biopsy Instrument K960064 Carefusion Achieve Automatic Biopsy System K141552 H.S. Hospital Service Biomol Aspiration Biopsy Needle K002947 5.2 Device Description The M.D.L. S.r.l. S… | 2014 |
| * | K002947 | Biomol Aspiration Biopsy NeedleSummary page 5…K960064 Carefusion Achieve Automatic Biopsy System K141552 H.S. Hospital Service Biomol Aspiration Biopsy Needle K002947 5.2 Device Description The M.D.L. S.r.l. Soft Tissues Biopsy Devices and Accessories include semi-automatic and automatic sprin… | 2000 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2021 | Class II | Z-2492-2021 | Other | Sterility assurance may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K212820 (Suzhou Leapmed Healthcare Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K934371.
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?
SemiCut Semi-Automatic Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Themy…
Read the full statement (280 words)
SemiCut Semi-Automatic Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.
Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.
Themy Automatic Biopsy Needle 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 abnormality.
Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone.
EasyCut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone.
MDL Biopsy Needle is intended for soft tissue core biopsy with Palium Reusable Automatic Biopsy Device. The device is not intended for use in bone.
Coaxial Introducer Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from it 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 as stated in the FDA summary.
https://510kreport.com/device/K160316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160316: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160316
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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