Cleared Special

K260857 - Sol-Guard™ Safety Pull Button Collection Set

Also marketed or referenced as:
Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set

K260857 is an FDA 510(k) clearance for Sol-Guard Safety Pull Button Collection Set, manufactured by Sol-Millennium Medical, Inc.. The device is a Class 2 General Hospital device with product code JKA cleared through the Special 510(k) pathway after a 219-day FDA review.

K260857 · Sol-Millennium Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
219d
Days
Class 2
Risk

K260857 is an FDA 510(k) clearance for the Sol-Guard™ Safety Pull Button Collection Set. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on October 21, 2026 after a review of 219 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260857

510(k) Number K260857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2026
Decision Date October 21, 2026
Days to Decision 219 days
Submission Type Special
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
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Modification to existing cleared device.

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 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 K260857.
Profoject™ Safe Push Button Blood Collection Sets
K262242 · CMT Health PTE., Ltd. · 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
Female Culture Device
K252899 · Zhejiang Kindly Medical Device Co., Ltd. · Jun 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
K260857 · Sol-Guard™ Safety Pull Button Collection Set
Download PDF FDA Summary Sol-Millennium Medica…