510(k) · Cleared
ClearedEvacore Fully Disposable Vacuum Assist Biopsy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pin-Point Care Corp. · KNW Instrument, Biopsy
Cleared on Jul 20, 2015 as substantially equivalent to K034021 (Suros Surgical Systems, Inc., 2004) after a 185-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jul 20, 2015
- Review
- 185 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K034021 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK034021 Vacuum Assisted Core Biopsy DeviceSuros Surgical Systems, Inc. · 2004
- This deviceK150088 Evacore Fully Disposable Vacuum Assist Biopsy DevicePin-Point Care Corp. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K034021 | Vacuum Assisted Core Biopsy Device | Suros Surgical Systems, Inc. | 2004 | — |
| 0 (this device) | K150088 | Evacore Fully Disposable Vacuum Assist Biopsy Device | Pin-Point Care Corp. | 2015 | — |
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 |
|---|---|---|---|
| * | K034021 | Vacuum Assisted Core Biopsy DeviceSummary page 4…ice Information: MantiTacEurer ssswwsmssusses Hologic — Suros Surgical Systems BeVics: conii i Celero Vacuum Assisted Spring Loaded Core Biopsy Device BT U] p | oo H—— K034021 V. Device Description: The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous b… | 2004 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K034021.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast. and lymph nodes. When used for breast biopsy, the product is for diagnosis only.
The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.
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/K150088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150088: Evacore Fully Disposable Vacuum Assist Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150088
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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