FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K Number: K163073
·
Decision May 19, 2017
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
13
Review Days
198
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Basic Information
- Device Name
- Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
- K Number
- K163073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sol-Millennium Medical, Inc.
- Date Received
- November 2, 2016
- Decision Date
- May 19, 2017
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Sol-Millennium Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Jun 18, 2026 | Substantially Equivalent |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Apr 30, 2025 | Substantially Equivalent |
| 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 | Nov 20, 2024 | Substantially Equivalent |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | Oct 22, 2024 | Substantially Equivalent |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sep 20, 2024 | Substantially Equivalent |
| K220713 | Sol-Guard Auto-disable Syringe | May 4, 2023 | Substantially Equivalent |
| K222744 | Sol-M Luer Lock Syringe | Oct 11, 2022 | Substantially Equivalent |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Aug 30, 2022 | Substantially Equivalent |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set | Dec 3, 2018 | Substantially Equivalent |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Aug 19, 2016 | Substantially Equivalent |