SOL-GUARD Safety Pull Button Collection Set— 510(k) K213718

Clearance details

Applicant

Sol-Millennium Medical, Inc.

Product code

Code JKA

Device class

Class 2

Regulation

21 CFR 862.1675

Advisory panel

Clinical Chemistry

Date received

2021-11-24

Decision date

2022-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suwanee, GA, US

• K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device2026-06-02
• K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes2026-04-15
• K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube2026-04-10
• K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder2026-04-10
• K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes2026-03-13

• K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
• K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18
• K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set2025-04-30
• K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle2024-11-20
• K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle2024-10-22

Injury

455

Malfunction

26,686

Other

4

Total

27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →