Cleared Traditional

K252899 - Female Culture Device

Also marketed or referenced as:
Male Culture Device Transfer Device Access Device

K252899 is an FDA 510(k) clearance for Female Culture Device, manufactured by Zhejiang Kindly Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K252899 · Zhejiang Kindly Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
264d
Days
Class 2
Risk

K252899 is an FDA 510(k) clearance for the Female Culture Device. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Zhejiang Kindly Medical Device Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on June 2, 2026 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K252899

510(k) Number K252899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2025
Decision Date June 02, 2026
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Shanghai Mind-Link Consulting Co., Ltd.
Evan Hu

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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 237
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K252899.
Sol-Guard™ Safety Pull Button Collection Set
K260857 · Sol-Millennium Medical, Inc. · Oct 2026
BD Vacutainer® Serum Blood Collection Tubes
K252344 · Becton, Dickinson and Company · Oct 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · CMT Health PTE., Ltd. · Sep 2026
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · Becton, Dickinson and Company · Apr 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
K252378 · Becton, Dickinson and Company · Apr 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · Becton, Dickinson and Company · Apr 2026
K252899 · Female Culture Device
Download PDF FDA Summary Zhejiang Kindly Medic…