510(k) · Cleared
ClearedBiomol Aspiration Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S. Hospital Service S.R.L. · FCG Biopsy Needle
Cleared on Dec 19, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 19, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002947 Biomol Aspiration Biopsy NeedleH.S. Hospital Service S.R.L. · 2000
- 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 · 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
- Descendant · 2 generations on · 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 5 of 5 · See all- K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · cites it directly4descendants
- 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
- K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd. · 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) | K002947 | Biomol Aspiration Biopsy Needle | H.S. Hospital Service S.R.L. | 2000 | — |
| +1 | K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… | M.D.L. S.R.L. | 2016 | 1 |
| +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 | — |
| +2 | K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and… | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 4 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium… | 2016 | 4 |
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 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/K002947 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002947: Biomol Aspiration Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002947
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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