510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221810Substantially Equivalent

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Bonraybio Co., Ltd., Taichung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221810 is the FDA 510(k) clearance record for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device, a class II device, cleared for Bonraybio Co., Ltd. on under FDA product code MQK (Labware, Assisted Reproduction). FDA records list 5 510(k) clearances for Bonraybio Co., Ltd., from to . As of , FDA records show no recalls naming K221810.

Clearance record

Decision date
Received
(131 days to decision)
Product code
MQK Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bonraybio Co., Ltd. 4f., # 118, Gongye 9th Rd., Dali Dist., Taichung, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQK

Trailing 12 months

FDA records hold no clearances under product code MQK in the trailing twelve months.

FDA records show no clearances under product code MQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260