510(k) · Cleared
Cleared22MM Siteselect Breast Biopsy Device Model SSD022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Surgical · KNW Instrument, Biopsy
Cleared on Aug 17, 2001 as substantially equivalent to K993936 (Imagyn Surgical, 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Aug 17, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K871390 (1987). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 2 generations backK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
- 1 generation backK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
- This deviceK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
- Descendant · cites it directly · 0 of its ownK040087 RabbitScion International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040087RabbitScion International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −2 | K963825 | Auto Suture* Abbi* System | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −1 | K983296 | Auto Suture Abbi System | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| 0 (this device) | K011575 | 22MM Siteselect Breast Biopsy Device Model SSD022 | Imagyn Surgical | 2001 | — |
| +1 | K040087 | Rabbit | Scion International, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993936 | 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM…Summary page 1…rade name: SiteSelect Breast Biopsy Device Classification name: Instrument, Biopsy 3. Devices to which substantial equivalence is claimed S10(k)# Device o Manufacturer K993936 SiteSelect Breast Biopsy Device Imagyn Surgical K972328 SiteSelect Breast Biopsy Device Imagyn Surgical K983296 ABBI USSC K95462… | 1999 |
| * | K972328 | Percutaneous Breast Biopsy (PBB)Summary page 1…n name: Instrument, Biopsy 3. Devices to which substantial equivalence is claimed S10(k)# Device o Manufacturer K993936 SiteSelect Breast Biopsy Device Imagyn Surgical K972328 SiteSelect Breast Biopsy Device Imagyn Surgical K983296 ABBI USSC K954628 ABBI USSC 4. Description of Device SiteSelect Breast… | 1998 |
| * | K983296 | Auto Suture Abbi SystemSummary page 1…ial equivalence is claimed S10(k)# Device o Manufacturer K993936 SiteSelect Breast Biopsy Device Imagyn Surgical K972328 SiteSelect Breast Biopsy Device Imagyn Surgical K983296 ABBI USSC K954628 ABBI USSC 4. Description of Device SiteSelect Breast Biopsy System consists of the SiteSelect device and the… | 1999 |
| Kept off the family tree | K954628 | ABBI Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…claimed S10(k)# Device o Manufacturer K993936 SiteSelect Breast Biopsy Device Imagyn Surgical K972328 SiteSelect Breast Biopsy Device Imagyn Surgical K983296 ABBI USSC K954628 ABBI USSC 4. Description of Device SiteSelect Breast Biopsy System consists of the SiteSelect device and the Site Select table… |
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 |
|---|---|---|---|
| K040087 | Rabbit | 2004 | 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 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040087 (Scion International, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993936.
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?
SiteSelect® is a disposable, single use diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from its…
Read the full statement (148 words)
SiteSelect® is a disposable, single use diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from its mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign.
SiteSelect is to be used in conjunction with a stereotactic mammographic imaging system capable of determining position of lesion within breast tissue.
This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.
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/K011575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011575: 22MM Siteselect Breast Biopsy Device Model SSD022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011575
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026