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 Mar 24, 2025 as substantially equivalent to K180061 (Bard Peripheral Vascular, Inc., 2018) after a 118-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Mar 24, 2025
- Review
- 118 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K063238 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK063238 Ultraclip II Wing and Ultraclip II CoilInrad · 2007
- 3 generations backK090547 Ultraclip II US Wing and Coil, Models: 862017U, 864017UC.R. Bard, Inc. · 2009 · Recalled
- 2 generations backK152510 UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2016
- 1 generation backK180061 UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2018
- This deviceK243642 UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K063238 | Ultraclip II Wing and Ultraclip II Coil | Inrad | 2007 | — |
| −3 | K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017U | C.R. Bard, Inc. | 2009 | 4 |
| −2 | K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2016 | — |
| −1 | K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2018 | — |
| 0 (this device) | K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K180061 | UltraCor Twirl Breast Tissue MarkerSummary page 5…nel: General & Plastic Surgery Regulation Number: 21 CFR 878.4300 3. Predicate Device: UltraCor™ Twirl™ Breast Tissue Marker (Ring shape; K180061) 4. Device Description: The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle app… | 2018 |
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 18 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243642: 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/K243642
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