510(k) · Cleared
ClearedBiopsy Sciences, LLC. Maxi-Cell Biopsy Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopsy Sciences, LLC · FCG Biopsy Needle
Cleared on Sep 3, 2002 as substantially equivalent to K822630 (Sherwood Medical Co., 1982) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1982. 1 of the 14 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Sep 3, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K822630 (1982). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK822630 Monoject Plastic Hub Spinal NeedleSherwood Medical Co. · 1982
- This deviceK021847 Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC · 2002
- Descendant · cites it directly · 9 of its ownK142688 Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014
- Descendant · 2 generations on · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled
- Descendant · 3 generations on · 2 of its ownK193517 ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX3 generations on · 2020
Most influential descendants
Showing 5 of 11 · See all- K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014 · cites it directly9descendants
- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · 2 generations on7descendants
- K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd. · 2021 · 2 generations on2descendants
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 3 generations on2descendants
- K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822630 | Monoject Plastic Hub Spinal Needle | Sherwood Medical Co. | 1982 | — |
| 0 (this device) | K021847 | Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles | Biopsy Sciences, LLC | 2002 | — |
| +1 | K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014 | — |
| +2 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| +2 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound… | Cook Ireland, Ltd. | 2021 | 1 |
| +3 | K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020 | Class I |
| +3 | K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K822630 | Monoject Plastic Hub Spinal NeedleSummary page 1…) 695-9269 F a : (714) 779-0406 Predicate Device(s1: KendalVSherwood Medical Plastic Hub Spinal Needle, K822630 and, Manan Westcott Biopsy Needles, K85 1 838. Device Description: The biopsy needle is a single lumen needle, identical… | 1982 |
| * | K851838 | Manan Chiba PTC NeedleSummary page 1…: (714) 779-0406 Predicate Device(s1: KendalVSherwood Medical Plastic Hub Spinal Needle, K822630 and, Manan Westcott Biopsy Needles, K85 1 838. Device Description: The biopsy needle is a single lumen needle, identical in design to the… | 1985 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K142688 (Cook Ireland, Ltd., 2014) has gone furthest, with 9 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 | — |
What is it indicated for?
The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021847
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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