510(k) · Cleared
ClearedBip Multi Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bip USA, Inc. · KNW Instrument, Biopsy
Cleared on Apr 28, 1994 after a 233-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 28, 1994
- Review
- 233 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK934371 Bip Multi ModificationBip USA, Inc. · 1994
- 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 · 0 of its ownK242228 Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01)…Triopsy Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK212820 Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK212822 Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK212819 Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · cites it directly4descendants
- K242228Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle…Triopsy Medical, Inc. · 2025 · cites it directly0descendants
- K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2022 · 2 generations on0descendants
- K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation · 2022 · 2 generations on0descendants
- K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934371 | Bip Multi Modification | Bip USA, Inc. | 1994 | — |
| +1 | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… | M.D.L. S.R.L. | 2016 | 1 |
| +1 | K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy… | Triopsy Medical, Inc. | 2025 | — |
| +2 | K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2022 | — |
| +2 | K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022 | — |
| +2 | K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 4 | 0 |
| 2025 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 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, K160316 (M.D.L. S.R.L., 2016) has gone furthest, with 4 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/K934371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934371: Bip Multi Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934371
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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