510(k) · Cleared
ClearedSingle Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · KNW Instrument, Biopsy
Cleared on Aug 14, 2002 as substantially equivalent to K012023 (Senorx, Inc., 2001) and 2 other predicates after an 83-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Aug 14, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K790187 (1979). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK790187 Bovie Hand ControlSybron Corp. · 1979
- 2 generations backK012004 Easy Guide Electrosurgical Access DeviceSenorx, Inc. · 2001
- 1 generation backK013641 Senorx Biopsy Device, Driver, Control Module, Including Accessories…Senorx, Inc. · 2002
- This deviceK021707 Single Step Biopsy Device, Single Step Surgical Handle, Single Step…Senorx, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790187 | Bovie Hand Control | Sybron Corp. | 1979 | — |
| −2 | K012004 | Easy Guide Electrosurgical Access Device | Senorx, Inc. | 2001 | — |
| −1 | K013641 | Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power… | Senorx, Inc. | 2002 | — |
| 0 (this device) | K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver… | Senorx, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 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 KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K012023 | Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSummary page 1…: Electrosurgical Accessory, 878.4400 3. IDENTIFICATION OF PREDICATE DEVICES Anchor GuideTM SenoRx Inc. (K012023) Localization and Fixation Device Shape SelectTM… | 2001 |
| * | K012799 | ES-2000 Shape Select Electrosurgical Scalpel | 2001 |
| * | K013641 | Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power… | 2002 |
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 23 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K012023.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The Single Step Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic 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/K021707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021707: Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021707
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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