510(k) · Cleared
ClearedEasy Core Biopsy System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FCG Biopsy Needle
Cleared on Feb 8, 2005 as substantially equivalent to K040893 (Boston Scientific Corp, 2004) after a 21-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Feb 8, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040893 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040893 Easy Core Biopsy SystemBoston Scientific Corp · 2004 · Recalled
- This deviceK050120 Easy Core Biopsy System IIBoston Scientific Corp · 2005
- Descendant · cites it directly · 1 of its ownK101832 Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK102756 Surecore Biopsy DeviceChest Innovations, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040893 | Easy Core Biopsy System | Boston Scientific Corp | 2004 | 19 |
| 0 (this device) | K050120 | Easy Core Biopsy System II | Boston Scientific Corp | 2005 | — |
| +1 | K101832 | Biopince Ultra Full Core Biopsy Instrument | Medical Device Technologies, Inc. | 2010 | — |
| +2 | K102756 | Surecore Biopsy Device | Chest Innovations, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040893 | Easy Core Biopsy SystemSummary page 1…Biopsy Instrument Classification: Class II, per 21 CFR Part 876.1075 PREDICATE DEVICE: Easy Core Biopsy System (K040893) DESCRIPTION: The proposed device is designed to simultaneously fire a stylet… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101832 | Biopince Ultra Full Core Biopsy Instrument | 2010 | 1 |
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?
- Its one ancestor has a recall.
- Of its descendants, K101832 (Medical Device Technologies, Inc., 2010) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050120: Easy Core Biopsy System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050120
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026