510(k) · Cleared
Recalled · Class II · 2024Bip Biopsy Needle Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bip USA, Inc. · FCG Biopsy Needle
Cleared on Mar 7, 1994 after a 181-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Mar 7, 1994
- Review
- 181 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK934370 Bip Biopsy Needle ModificationBip USA, Inc. · 1994
- Descendant · cites it directly · 0 of its ownK242228 Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01)…Triopsy Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242228Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle…Triopsy Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934370 | Bip Biopsy Needle Modification | Bip USA, Inc. | 1994 | — |
| +1 | K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy… | Triopsy Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2024 | Class II | Z-3206-2024 | Packaging change control | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. |
| Oct 8, 2009 | Not classified | Z-0273-2010 | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample… |
| Oct 8, 2009 | Not classified | Z-0274-2010 | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample… |
| Oct 8, 2009 | Not classified | Z-0275-2010 | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample… |
| Oct 8, 2009 | Not classified | Z-0276-2010 | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K242228 (Triopsy Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K934370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K934370: Bip Biopsy Needle Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934370
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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