510(k) · Cleared
ClearedPro-B Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedical, Ltd. · FCG Biopsy Needle
Cleared on Apr 21, 1995 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 21, 1995
- Review
- 14 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK951598 Pro-B Biopsy NeedlePromedical, Ltd. · 1995
- Descendant · cites it directly · 0 of its ownK013069 BiospeedH.S. Hospital Services S.P.A. · 2001
- Descendant · cites it directly · 0 of its ownK964777 TZGallini Intl., Inc. · 1997
- Descendant · cites it directly · 0 of its ownK962905 TX Biopsy NeedleGallini S.R.L. · 1996
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951598 | Pro-B Biopsy Needle | Promedical, Ltd. | 1995 | — |
| +1 | K013069 | Biospeed | H.S. Hospital Services S.P.A. | 2001 | — |
| +1 | K964777 | TZ | Gallini Intl., Inc. | 1997 | — |
| +1 | K962905 | TX Biopsy Needle | Gallini S.R.L. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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? (3)
3 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, K013069 (H.S. Hospital Services S.P.A., 2001) 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/K951598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951598: Pro-B Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951598
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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