510(k) · Cleared
ClearedMielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterylab S.R.L. · FCG Biopsy Needle
Cleared on Jul 27, 2005 as substantially equivalent to K980196 (Medical Device Technologies, Inc., 1998) and 3 other predicates after a 50-day review. Its family tree reaches back 5 generations to 1987. 1 of the 37 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it.
- Decided
- Jul 27, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K871390 (1987). 18 ancestors in all. 18 later devices descend from it, 3 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 4 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 3 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 2 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 1 generation backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- This deviceK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- Descendant · cites it directly · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- Descendant · 2 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
- Descendant · 2 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
- Descendant · cites it directly · 3 of its ownK070759 Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK142377 The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC · 2014 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrowdirect predicate · 1998
Most influential descendants
Showing 5 of 18 · See all- K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · cites it directly12descendants
- K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 2 generations on5descendants
- K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 2 generations on4descendants
- K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation · 2007 · cites it directly3descendants
- K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −4 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −3 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −2 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −1 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| 0 (this device) | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| +1 | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
| +2 | K140991 | Ranfac Aspiration Needle with Adjustable Guide | Ranfac, Corp. | 2014 | — |
| +2 | K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015 | — |
| +1 | K070759 | Powered EZ-IO Pediatric Bone Marrow Aspiration System | Vidacare Corporation | 2007 | — |
| +2 | K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | Vidacare, LLC | 2014 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K980196 | MD Tech Biopsy Set for Bone and Bone MarrowSummary page 1…set, gastro-urology KNW - Biopsy instrument Predicate Devices: MD Tech K980196 - Manan Biopsy Set for Bone and Bone Marrow K974814- Manan Super Core Biopsy… | 1998 |
| * | K974814 | Manan (TM) Super-Core Biopsy NeedlesSummary page 1…ate Devices: MD Tech K980196 - Manan Biopsy Set for Bone and Bone Marrow K974814- Manan Super Core Biopsy K990839 - Tru-Core 1 Reusable biopsy instrument… | 1998 |
| * | K990839 | Tru-Core I Reusable Biopsy InstrumentSummary page 1…K980196 - Manan Biopsy Set for Bone and Bone Marrow K974814- Manan Super Core Biopsy K990839 - Tru-Core 1 Reusable biopsy instrument K980226 - Manan Pro-Mag Automatic Biopsy system… | 1999 |
| * | K980226 | Manan Pro-Mag Automatic Biopsy SystemSummary page 1…K974814- Manan Super Core Biopsy K990839 - Tru-Core 1 Reusable biopsy instrument K980226 - Manan Pro-Mag Automatic Biopsy system IDevice Description… | 1998 |
What descends from it? (18)
See all 183 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.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131157 (Ranfac, Corp., 2013) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K980196.
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?
Bone and Bone marrow biopsy devices - Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices - Spring-Cut, Die-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft…
Read the full statement (176 words)
Bone and Bone marrow biopsy devices - Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients.
Soft Tissue Devices - Spring-Cut, Die-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited tO, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographid'appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051506
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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