510(k) · Cleared
ClearedBiopsy Accessory for Ultrasound Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 9, 1997 as substantially equivalent to K912088 (Biosound, Inc., 1991) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 9, 1997
- Review
- 62 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831317 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831317 Biopsy AttachmentDiasonics, Inc. · 1983
- This deviceK971700 Biopsy Accessory for Ultrasound TransducerBiosound, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831317 | Biopsy Attachment | Diasonics, Inc. | 1983 | — |
| 0 (this device) | K971700 | Biopsy Accessory for Ultrasound Transducer | Biosound, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K912088 | Biopsy Accessories for Ultrasound ProbesSummary page 1…and handle Common Name: Punch, biopsy Classification Name(s): Punch, biopsy 876.1075 807.92(a)(3) Predicate Device(s) Company Article 510 (k) Esaote ABS1, ABS2, ABS3, K912088 Diasonics New Image K831317 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence C… | 1991 |
| * | K831317 | Biopsy AttachmentSummary page 1…ch, biopsy Classification Name(s): Punch, biopsy 876.1075 807.92(a)(3) Predicate Device(s) Company Article 510 (k) Esaote ABS1, ABS2, ABS3, K912088 Diasonics New Image K831317 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table. kG 71760… | 1983 |
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?
- None of the 2 ancestors has a recall.
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?
The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971700: Biopsy Accessory for Ultrasound Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971700
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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