510(k) · Cleared
ClearedBearing nsPVA Express™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Dec 21, 2023 as substantially equivalent to K130259 (Merit Medical Systems, Inc., 2013) after a 21-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Dec 21, 2023
- Review
- 21 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961923 (1996). 10 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 5 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 4 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 3 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 2 generations backK100663 Contour Embolization Particles, Models M0017600121, M0017600221…Boston Scientific Corporation · 2010
- 1 generation backK130259 Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc. · 2013
- This deviceK233813 Bearing nsPVA Express™Merit Medical Systems, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −6 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −5 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −4 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −3 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −2 | K100663 | Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | 2010 | — |
| −1 | K130259 | Bearing Nspva Embolization Particles | Merit Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 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 NAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K130259 | Bearing Nspva Embolization ParticlesSummary page 5…Merit Medical Systems, Inc. Trade Name: Bearing™ nsPVA Embolization Particles Predicate Premarket Notification: K130259 Device Manufacturer: Merit Medical Systems, Inc. The predicate device has not been… | 2013 |
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 27 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All NAJ devicesNAJ Agents, Embolic, For Treatment Of Uterine Fibroids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAJ
Too few NAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAJ
3in 2025
MAUDE reports naming product code NAJ, 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 | 0 | — | 0 | 46 |
| 2008 | 1 | — | 0 | 23 |
| 2009 | 0 | — | 1 | 11 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
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/K233813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233813: Bearing nsPVA Express™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233813
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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