Cleared Traditional

K232579 - Twoplus Applicator (FDA 510(k) Clearance)

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

K232579 · Hannah Life Technologies Pte , Ltd. · Obstetrics & Gynecology device
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Dec 2023
Decision
118d
Days
Class 2
Risk

K232579 is an FDA 510(k) clearance for the Twoplus Applicator. Classified as At Home Intravaginal Insemination System (product code QYZ), Class II - Special Controls.

Submitted by Hannah Life Technologies Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on December 21, 2023 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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 Hannah Life Technologies Pte , Ltd. devices

Submission Details

510(k) Number K232579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2023
Decision Date December 21, 2023
Days to Decision 118 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 160d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QYZ At Home Intravaginal Insemination System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
Definition To Deliver Semen To The Vaginal Canal For Insemination.
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

Matrix Medical Consulting, Inc.
Alan Donald

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.