Cleared Traditional

K262066 - Pleiades Device

K262066 is an FDA 510(k) clearance for Pleiades Device, manufactured by My123Baby Medical Limited Dba Boost Fertility. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K262066 · My123Baby Medical Limited Dba Boost Fertility · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
130d
Days
Class 2
Risk

K262066 is an FDA 510(k) clearance for the Pleiades Device. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by My123Baby Medical Limited Dba Boost Fertility (Munich, DE). The FDA issued a Cleared decision on October 30, 2026 after a review of 130 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.

FDA 510(k) Submission Details - K262066

510(k) Number K262066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date October 30, 2026
Days to Decision 130 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
31d faster than avg
Panel avg: 161d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQK Device Classification - Class 2, Special Controls

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

Proxima CRO
Carmen Brown

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 52
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K262066 · Pleiades Device
Download PDF FDA Summary My123Baby Medical Lim…