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Sol-Guard XtraThin Safety Pull-Button Blood Collection Set

by Sol-Millennium Medical, Inc.

510(k) K250907Ref PBFLA2507, PBFLA2312, PBFLA2112, PBFH2307, PBFLA2307

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250907↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006243SPB12J Basic UDI-DI Date15 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED Number081006243SPB12J Basic UDI-DI Date15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK250907 Date30 Apr 2025ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
Trade Name
SOL-GUARD XtraThin Safety Pull-Button Blood Collection Set with Luer Adapter
SOL-GUARD XtraThin Safety Pull-Button Blood Collection Set with Pre-attached Holder
Device Name
Safety Pull-Button Blood Collection/Infusion Set
Model / Reference
PBFLA2507, PBFLA2312, PBFLA2112, PBFH2307, PBFLA2307
Primary DI / UDI-DI
00840368510946, 00840368501081, 00840368501074, 00840368511035, 00840368510915
Basic UDI-DI
081006243SPB12J
Direct Marketing DI
00840368510946
00840368501081
00840368501074
00840368511035
00840368510915
510(k) Number
FDA Product Code
JKA
EMDN Code
A01010201 Butterfly needles, with safety systems
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 862.1675
EU market of registration
Poland
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sol-Guard XtraThin Safety Pull-Button Blood Collection Set is a blood collection device designed for safe and secure venipuncture procedures. It features a pull-button mechanism to enhance safety by reducing needle exposure risk during blood draw procedures, aligning with the nomenclature for safety-engineered blood collection systems.

This set is intended for single-use in clinical chemistry applications, as classified under product code JKA. Supplied sterile and packaged for healthcare settings, it adheres to FDA 510(k) clearance, MDD, and MDR regulatory standards. The device is non-magnetic and compatible with standard blood collection practices, ensuring reliability in laboratory and diagnostic environments.

Other devices from Sol-Millennium Medical, Inc.

See all devices from Sol-Millennium Medical, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What makes the Sol-Guard XtraThin Safety Pull-Button Blood Collection Set safer than traditional blood collection sets during venipuncture?

    The Sol-Guard XtraThin features a pull-button mechanism, which reduces needle exposure risk by allowing the user to safely retract the needle after blood collection. This design minimizes accidental sticks or pricks, aligning with modern safety-engineered blood collection systems while maintaining compatibility with standard laboratory practices.

  • Is this device intended for reuse in clinical settings, or is it designed for single-use only?

    The Sol-Guard XtraThin is explicitly designed for single-use in clinical chemistry applications, as indicated by its classification under product code JKA. Single-use ensures patient safety and sterility, preventing cross-contamination between procedures.

  • How is the Sol-Guard XtraThin packaged, and is it sterile when received?

    The device is supplied sterile and packaged specifically for healthcare settings, ensuring it meets infection control standards before use. The sterile packaging is standard for blood collection sets to maintain integrity until deployment in clinical environments.

  • What regulatory standards does this device comply with, and how does that affect its use?

    The Sol-Guard XtraThin complies with FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) standards. These approvals confirm its safety, performance, and compliance with EU and U.S. requirements, ensuring reliable use in laboratory and diagnostic settings without additional local validation.

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No