510(k) · Cleared
ClearedHRSpheres Narrow-Size Embolic Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Hengrui Hongyuan Medical Co., Ltd. · KRD Device, Vascular, For Promoting Embolization
Cleared on Oct 1, 2021 as substantially equivalent to K173871 (Suzhou Hengrui Callisyn Biomedical Co., Ltd., 2018) after a 218-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 1, 2021
- Review
- 218 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961923 (1996). 9 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 2 generations backK150876 Bead BlockBiocompatibles UK, Ltd. · 2016
- 1 generation backK173871 CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd. · 2018
- This deviceK210562 HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −5 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −4 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −3 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −2 | K150876 | Bead Block | Biocompatibles UK, Ltd. | 2016 | — |
| −1 | K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018 | — |
| 0 (this device) | K210562 | HRSpheres Narrow-Size Embolic Microspheres | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021 | — |
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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSummary page 4…3. Predicate Device Device Name: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres 510(k) number: K173871 Manufacturer: Suzhou Hengrui Callisyn Biomedical Co., Ltd Regulation Number: 21 CFR 870.3300 Product Code:… | 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 25 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K173871.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
HRSpheres Narrow-Size Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210562: HRSpheres Narrow-Size Embolic Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210562
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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