510(k) · Cleared
ClearedBiopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-K Medical Aps · FCG Biopsy Needle
Cleared on Jul 22, 2008 as substantially equivalent to K073399 (Envisioneering, LLC, 2007) after a 71-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Jul 22, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875128 (1988). 16 ancestors in all, the oldest K851831 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- 3 generations backK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- 2 generations backK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- 1 generation backK073399 Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007
- This deviceK081323 Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy…B-K Medical Aps · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −3 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| −2 | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| −1 | K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | Envisioneering, LLC | 2007 | — |
| 0 (this device) | K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 | B-K Medical Aps | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 6 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideSummary page 1…ssification: Kit, needle biopsy FCG (CFR 876.1075) Class II Identification of predicate, legally marketed device: Targetscan biopsy kit, Targetscan biopsy needle guide (K073399) Device description: The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Performing ultrasound guided biopsies of the prostate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081323: Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081323
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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