Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set— 510(k) K250907
Substantially EquivalentSol-Millennium Medical, Inc.
FDA 510(k) clearance K250907 for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set, Substantially Equivalent on 2025-04-30. Applicant: Sol-Millennium Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sol-Millennium Medical, Inc.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chicago, IL, US
Recent devices under product code JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Sol-Millennium Medical, Inc.
view all- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- 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 Needle
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
- K241821 — Luer Lock Syringe with Safety Needle +2 more
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.