510(k) · Cleared
ClearedCalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Hengrui Callisyn Biomedical Co., Ltd. · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Sep 17, 2018 as substantially equivalent to K150876 (Biocompatibles UK, Ltd., 2016) after a 271-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 17, 2018
- Review
- 271 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961923 (1996). 8 ancestors in all, the oldest K871047 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 4 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 3 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 2 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 1 generation backK150876 Bead BlockBiocompatibles UK, Ltd. · 2016
- This deviceK173871 CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK250209 Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232934 SunsphereHangzhou Yangshun Medical Technology Co.,Ltd · 2024
- Descendant · cites it directly · 0 of its ownK210562 HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K250209Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc. · 2025 · cites it directly0descendants
- K232934SunsphereHangzhou Yangshun Medical Technology Co.,Ltd · 2024 · cites it directly0descendants
- K210562HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −4 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −3 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −2 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −1 | K150876 | Bead Block | Biocompatibles UK, Ltd. | 2016 | — |
| 0 (this device) | K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018 | — |
| +1 | K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025 | — |
| +1 | K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 NAJ? 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 NAJ device
- #1 K233813 Bearing nsPVA Express™score 8.3 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K150876 | Bead BlockSummary page 5…(device, embolization, arterial), NAJ (agents, embolic, for treatment of uterine fibroids) 3 Predicate Device Device Name: Bead Block™ 510(k) number: K150876 Manufacturer: Biocompatibles UK Ltd. Regulation Number: 21CFR 870.3300 Product code: KRD (device, embolization,… | 2016 |
| † | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization | 2002 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K250209 (Canyon Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2018, 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?
Callispheres Embolic Microspheres and 8Spheres 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/K173871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173871
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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