510(k) · Decided
DecidedTargetscan Biopsy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisioneering, LLC · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 2, 2004 as substantially equivalent to K980122 (Medical Device Technologies, Inc., 1998) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Sep 2, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851831 (1985). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK851831 Manan Franseene NeedleManan Manufacturing Co., Inc. · 1985
- 1 generation backK980122 Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc. · 1998
- This deviceK041638 Targetscan Biopsy KitEnvisioneering, LLC · 2004
- Descendant · cites it directly · 1 of its ownK073399 Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK081323 Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy…B-K Medical Aps · 2008
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 |
|---|---|---|---|---|---|
| −2 | K851831 | Manan Franseene Needle | Manan Manufacturing Co., Inc. | 1985 | — |
| −1 | K980122 | Manan Soft Tissue Biopsy Needles | Medical Device Technologies, Inc. | 1998 | — |
| 0 (this device) | K041638 | Targetscan Biopsy Kit | Envisioneering, LLC | 2004 | — |
| +1 | K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | Envisioneering, LLC | 2007 | — |
| +2 | 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 | 5 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K980122 | Manan Soft Tissue Biopsy NeedlesSummary page 1…Instrument, as defined in CFR 876.1075, a Class II device. 8. Identification of Predicate Device(s): *Manan Biopsy needle (Medical Device Technology K980122) *EP Deflectable Catheter, (EP Medsystemns K033963) 9. Device Description: The sterile TargetScan'T… | 1998 |
| * | K033963 | EP Deflectable CathetersSummary page 1…8. Identification of Predicate Device(s): *Manan Biopsy needle (Medical Device Technology K980122) *EP Deflectable Catheter, (EP Medsystemns K033963) 9. Device Description: The sterile TargetScan'TM biopsy kit is designed to be used with the Targetscan M… | 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 |
|---|---|---|---|
| K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | 2007 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K073399 (Envisioneering, LLC, 2007) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K980122.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
This device is indicated for performing planned and targeted ultrasound guided transrectal
biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041638: Targetscan Biopsy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041638
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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