Pharma-Plast Needle
FDA 510(k) K852442 · Pharma-Plast USA, Inc.
510(k) numberK852442
Submission
- Device name
- Pharma-Plast Needle
- Applicant
- Pharma-Plast USA, Inc.
Canada H3a 2n4, CA - Received
- June 10, 1985
- Decision date
- September 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K894371 | Nipro Safelet CathFOZ · Traditional | 10/25/1989SE |
| K894373 | Nipro Dental NeedleDZM · Traditional | 10/13/1989SE |
| K894374 | Blood Drawing NeedleFMI · Traditional | 09/28/1989SE |
| K894372 | Nipro Needle HolderFMI · Traditional | 09/28/1989SE |
| K884978 | Pharma-Plast Insulin Infusion SetLZG · Traditional | 06/21/1989SE |
| K871263 | Multiple Pharma-Plast Tracheal TubeBTR · Traditional | 06/15/1987SE |
| K852444 | Asik 'Once' SyringeFMF · Traditional | 10/16/1985SE |
| K852443 | Pharma-Plast ClinipakFMF · Traditional | 10/16/1985SE |
Questions and answers
When was Pharma-Plast Needle cleared by the FDA?
Pharma-Plast Needle (K852442) received a 510(k) decision of Substantially Equivalent on September 20, 1985, 102 days after the submission was received.
What is the product code of K852442?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.