Medline Syringes, Multiple
510(k) K061275
Medline Syringes, Multiple is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K061275 on 19 Jul 2006, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061275 | Date19 Jul 2006 | StatusActive |
Official records
- FDA 510(k) database K061275
Recalls
-
- Ongoing Z-1937-2024
- Ongoing Z-1938-2024
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Timeline
- Cleared FDA 510(k) K061275
- Recall initiated FDA recalls Z-1937-2024
- Recall initiated FDA recalls Z-1938-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMF
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code FMF (Syringe, Piston).
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- DISPOSABLE DISC FILTER by The Medi-Dose Group
- COLORLESS DISPOSIBLE PLASTIC SYRINGES by Sam Joo Industrial Co., Ltd.