Submission Details
| 510(k) Number | K251350 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2025 |
| Decision Date | July 29, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
BD Plastipak? Syringe
Jul 2025
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K251350 is an FDA 510(k) clearance for the BD Plastipak? Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 29, 2025, 90 days after receiving the submission on April 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
Similar Devices — FMF Syringe, Piston
All 747
K253068 · CMT Health PTE., Ltd.
· Feb 2026
K253769 · Instylla, Inc.
· Dec 2025
K252518 · Duopross Meditech Corporate
· Dec 2025
K251089 · Exelint International, Co.
· Dec 2025
K250192 · Promisemed Hangzhou Meditech Co., Ltd.
· Dec 2025
K250853 · Merit Medical Systems, Inc.
· Nov 2025
More from Becton, Dickinson and Company
View all
K252040
· JKA · Mar 2026
K250884
· NGT · Dec 2025
K250358
· PCI · Oct 2025
K250059
· ONB · Sep 2025
K251713
· LON · Aug 2025