510(k) · Cleared
ClearedTargetscan Biopsy Kit, Targetscan Biopsy Needle Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisioneering, LLC · FCG Biopsy Needle
Cleared on Dec 21, 2007 as substantially equivalent to K041638 (Envisioneering, LLC, 2004) and 1 other predicate after a 17-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Dec 21, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K875128 (1988). 15 ancestors in all, the oldest K851831 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- 2 generations backK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- 1 generation backK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- This deviceK073399 Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007
- Descendant · cites it directly · 0 of its ownK081323 Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy…B-K Medical Aps · 2008
Most influential descendants
Showing 1 of 1 · See all- K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −2 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| −1 | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| 0 (this device) | K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | Envisioneering, LLC | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K041638 | Targetscan Biopsy KitSummary page 1…Biopsy Kit FCG Needle Guide ITX Identification of Predicate Device(s): Envisioneering TargetScan® Biopsy Kit 510(k) # K041638, originally cleared September 2, 2004. Envisioneering TargetScan® Biopsy Needle Guide 5 10(k) # K041637, originally cleared Se… | 2004 |
| * | K041637 | Targetscan Transrectal Ultrasound SystemSummary page 1…cate Device(s): Envisioneering TargetScan® Biopsy Kit 510(k) # K041638, originally cleared September 2, 2004. Envisioneering TargetScan® Biopsy Needle Guide 5 10(k) # K041637, originally cleared September 1, 2004. Device Description: The sterile TargetScan® biopsy kit and Guide are designed to be… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 | 2008 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K081323 (B-K Medical Aps, 2008) has gone furthest, with 0 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. 2007, 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?
The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073399
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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