510(k) · Decided
DecidedBard Monopty Disposable Core Biopsy Isnt. W/ Cent.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNW Instrument, Biopsy
Cleared on Feb 16, 1993 after a 243-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Feb 16, 1993
- Review
- 243 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 3 citing it directly.
- This deviceK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
- Descendant · cites it directly · 27 of its ownK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 11 of its ownK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
- Descendant · 2 generations on · 5 of its ownK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 4 of its ownK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Bard Peripheral Vascular, Inc. · 2014 · cites it directly27descendants
- K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014 · 2 generations on11descendants
- K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · 2 generations on5descendants
- K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · 3 generations on4descendants
- K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K141552 | Achieve Programmable Auomated Biopsy Systems | Care Fusion | 2014 | — |
| +2 | K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017 | 3 |
| +3 | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… | M.D.L. S.R.L. | 2016 | 1 |
| +3 | K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (31)
See all 313 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, K133948 (Bard Peripheral Vascular, Inc., 2014) has gone furthest, with 27 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/K922939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922939: Bard Monopty Disposable Core Biopsy Isnt. W/ Cent..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922939
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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