510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K210562Substantially Equivalent

HRSpheres Narrow-Size Embolic Microspheres

Suzhou Hengrui Hongyuan Medical Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210562 is the FDA 510(k) clearance record for HRSpheres Narrow-Size Embolic Microspheres, a class II device, cleared for Suzhou Hengrui Hongyuan Medical Co., Ltd. on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list 2 510(k) clearances for Suzhou Hengrui Hongyuan Medical Co., Ltd., from to . As of , FDA records show no recalls naming K210562.

Clearance record

Decision date
Received
(218 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Suzhou Hengrui Hongyuan Medical Co., Ltd. Bldg. B9 Unit 201, # 218 Xinghu Rd., Sip,, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRD

Trailing 12 months
7 clearances under product code KRD in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20260