510(k) · Cleared
ClearedIntact® Gen2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intact Medical Corporation · KNW Instrument, Biopsy
Cleared on Feb 15, 2016 as substantially equivalent to K142477 (Intact Medical Corporation, 2014) after a 158-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Feb 15, 2016
- Review
- 158 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003297 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003297 Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc. · 2001
- 3 generations backK060413 Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006
- 2 generations backK081057 Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008
- 1 generation backK142477 Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014
- This deviceK152596 Intact® Gen2 SystemIntact Medical Corporation · 2016
- Descendant · cites it directly · 0 of its ownK252183 Resitu Slider 09 (RESL09)Resitu Medical AB · 2025
Most influential descendants
Showing 1 of 1 · See all- K252183Resitu Slider 09 (RESL09)Resitu Medical AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003297 | Mammotome Hand Held Probe, Model MHH8 | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −3 | K060413 | Intact Breast Lesion Excision System and Advance | Intact Medical Corporation | 2006 | — |
| −2 | K081057 | Intact Breast Lesion Excision System with Intact Excision XL | Intact Medical Corporation | 2008 | — |
| −1 | K142477 | Intact Advance and Intact Excision XL, Intact BLES | Intact Medical Corporation | 2014 | — |
| 0 (this device) | K152596 | Intact® Gen2 System | Intact Medical Corporation | 2016 | — |
| +1 | K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K142477 | Intact Advance and Intact Excision XL, Intact BLESSummary page 4…Product Code KNW Predicate Device Intact® BLES with Intact® Excision XL wand and handle (K142477) Device Description The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample t… | 2014 |
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 |
|---|---|---|---|
| K252183 | Resitu Slider 09 (RESL09) | 2025 | 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 15 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252183 (Resitu Medical AB, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Intact® Gen2 System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. • The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. • The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. • The Intact® Gen2 System is intended to preserve lesion…
Read the full statement (227 words)
• The Intact® Gen2 System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
• The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
• The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
• The Intact® Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact® Gen2 System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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/K152596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152596: Intact® Gen2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152596
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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