Cleared Traditional

K221810 - LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221810 · Bonraybio Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
131d
Days
Class 2
Risk

K221810 is an FDA 510(k) clearance for the LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Bonraybio Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 31, 2022 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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 Bonraybio Co., Ltd. devices

Submission Details

510(k) Number K221810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date October 31, 2022
Days to Decision 131 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
29d faster than avg
Panel avg: 160d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 Consultant

Ivdd Regulatory Consultant
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 49
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K221810.
SperSort™ Sperm Sorting Chip (IPG02)
K241626 · Ipreg Incorporation · Feb 2025
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
K241454 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2025
SwimCount® Harvester (1 mL)
K241348 · Motilitycount Aps · Jan 2025
cryo-GO Vitrification Device
K241341 · Fujifilm Irvine Scientific · Sep 2024
G-Vitri™ Vitrification Straw
K240002 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 2024
SpermAlign Sperm Separation Device
K232980 · Cytoswim, Ltd. · Mar 2024