FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
K Number: K182146
·
Decision Dec 3, 2018
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
13
Review Days
117
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Basic Information
- Device Name
- Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
- K Number
- K182146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sol-Millennium Medical, Inc.
- Date Received
- August 8, 2018
- Decision Date
- December 3, 2018
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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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 |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | May 19, 2017 | Substantially Equivalent |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Aug 19, 2016 | Substantially Equivalent |