Cleared Traditional

K210562 - HRSpheres Narrow-Size Embolic Microspheres

K210562 is an FDA 510(k) clearance for HRSpheres Narrow-Size Embolic Microspheres, manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code KRD cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K210562 · Suzhou Hengrui Hongyuan Medical Co., Ltd. · Obstetrics & Gynecology device
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Oct 2021
Decision
218d
Days
Class 2
Risk

K210562 is an FDA 510(k) clearance for the HRSpheres Narrow-Size Embolic Microspheres. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Suzhou Hengrui Hongyuan Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 1, 2021 after a review of 218 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.3300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Hengrui Hongyuan Medical Co., Ltd. devices

FDA 510(k) Submission Details - K210562

510(k) Number K210562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2021
Decision Date October 01, 2021
Days to Decision 218 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 160d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 97
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