Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
by Sol-Millennium Medical, Inc.
510(k) K182146
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK182146 | Date3 Dec 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Sol-M Blood Collection Needles and related sets are venipuncture devices designed for safe and efficient blood collection. They include standard blood collection needles, safety-engineered needles with protective sheaths, and preassembled sets with holders, all intended to minimise occupational exposure and improve procedural safety during phlebotomy.
These devices are supplied sterile and intended for single-use in clinical settings such as hospitals and outpatient facilities. They comply with FDA 510(k) clearance (K182146) and EU regulatory standards (MDD, MDR), ensuring adherence to safety and performance requirements. The safety variants incorporate a retractable or sheathing mechanism to reduce needle-stick injuries, while the set configurations include compatible tubing and adapters for direct connection to collection systems.
Other devices from Sol-Millennium Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these needles designed for reuse in clinical settings, or are they meant to be used only once per patient?
These devices are explicitly intended for single-use only in clinical settings like hospitals and outpatient facilities. The manufacturer emphasizes sterility upon supply, which aligns with single-use protocols to prevent cross-contamination and ensure patient and clinician safety.
What safety features do the Sol-Care Safety Blood Collection Needles include to reduce occupational exposure?
The Sol-Care Safety Blood Collection Needles incorporate a retractable or sheathing mechanism, which automatically covers the needle after use. This design minimizes the risk of needle-stick injuries during or after phlebotomy, enhancing occupational safety for healthcare workers.
Do these blood collection sets come preassembled with tubing and adapters, or do I need to purchase them separately?
The Sol-M Blood Collection Set is supplied as a preassembled configuration, including compatible tubing and adapters. This allows for direct connection to blood collection systems without additional assembly, streamlining the phlebotomy process.
What regulatory pathways have these devices undergone, and which standards do they comply with?
These devices have received FDA 510(k) clearance (K182146) under the Traditional pathway, with a decision of *Substantially Equivalent* for the General Hospital category. They also comply with EU regulatory standards (MDD and MDR), ensuring adherence to safety and performance requirements in both markets.
Are there different sizes or models available, or is this a one-size-fits-all solution for blood collection?
While the provided data does not specify exact gauge sizes or model variations, the product line includes standard blood collection needles, safety-engineered variants, and preassembled sets with holders. Clinicians should consult the manufacturer’s catalog or technical documentation for precise sizing options to match patient needs and procedural requirements.