Ningbo Medsun Medical Co., Ltd. · Class II · Cleared Mar 18, 2026
| K-number | K253622 |
| Device name | Safety Pen Needle |
| Applicant | Ningbo Medsun Medical Co., Ltd. |
| Product code | FMI |
| Device class | Class II |
| Decision date | Mar 18, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.5570 |
The Safety Pen Needle is a sterile, single-use hypodermic needle designed for subcutaneous injection of drugs using pen injector devices. It features sharps protection at both the patient end and cartridge end, available in two models: SD with a 3-bevel needle tip and SDW with a 5-bevel needle tip. The needle is made of stainless steel, sterilized by ethylene oxide gas, with a 5-year shelf life.
Compared to the predicate device (K210864), the subject device includes an additional needle gauge option (32.5G), offers both 3-bevel and 5-bevel needle tip designs versus only 3-bevel in the predicate, uses EO sterilization instead of gamma irradiation, and includes silicone oil lubricant and UV glue adhesive. Core similarities include twist-on attachment, manual operation, thin-wall needle tube, and identical needle lengths (4mm, 5mm, 6mm, 8mm).
ISO 9626 (stainless steel needle tubing), ISO 11608-2 (needle-based injection systems), ISO 7864 (sterile hypodermic needles), ISO 23908 (sharps injury protection), ISO 10993 series (biocompatibility), ASTM F756-17 (hemocompatibility), and FDA Guidance on Medical Devices with Sharps Injury Prevention Features.
View the full FDA submission: accessdata.fda.gov