510(k) · Cleared
ClearedUltraCor Twirl Breast Tissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · NEU Marker, Radiographic, Implantable
Cleared on May 13, 2016 as substantially equivalent to K090547 (C.R. Bard, Inc., 2009) after a 254-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- May 13, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063238 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK063238 Ultraclip II Wing and Ultraclip II CoilInrad · 2007
- 1 generation backK090547 Ultraclip II US Wing and Coil, Models: 862017U, 864017UC.R. Bard, Inc. · 2009 · Recalled
- This deviceK152510 UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK180061 UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK243642 UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063238 | Ultraclip II Wing and Ultraclip II Coil | Inrad | 2007 | — |
| −1 | K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017U | C.R. Bard, Inc. | 2009 | 4 |
| 0 (this device) | K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2016 | — |
| +1 | K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2018 | — |
| +2 | K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 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 |
|---|---|---|---|
| * | K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017USummary page 4…iew Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4300 (Implantable Clip) Predicate Device: UltraClip® II US Wing and Coil (K090547, Cleared March 18, 2009) Summary of Change: The modifications from the predicate device, the UltraClip® II US Wing and Coil Br… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180061 | UltraCor Twirl Breast Tissue Marker | 2018 | 1 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K180061 (Bard Peripheral Vascular, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The UltraCor Twirl Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152510: UltraCor Twirl Breast Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152510
Report an extraction error
Are you the manufacturer?
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