Terumo Medical Products (Hangzhou) Co., Ltd. · Class II · Cleared Dec 18, 2025
| K-number | K252402 |
| Device name | Midline Catheter |
| Applicant | Terumo Medical Products (Hangzhou) Co., Ltd. |
| Product code | PND |
| Device class | Class II |
| Decision date | Dec 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5200 |
The Midline Catheter is a peripherally inserted catheter for short-term use (less than 30 days) to sample blood or administer intravenous fluids. It features a polyurethane catheter with a passive safety mechanism on the needle and is compatible with power injectors for all patient populations.
The device has similar construction to the predicate PowerGlide Pro Midline Catheter (K162377) but differs in guidewire component (subject device has none) and tip configuration. Both use polyurethane catheters, stainless steel needles, and passive safety shields with equivalent power injection flow rates (18G=7mL/sec, 20G=5mL/sec, 22G=2mL/sec).
ISO 10555-1 (intravascular catheters), ISO 10993 series (biocompatibility), ISO 11135 (ethylene oxide sterilization), ASTM F2052-21, F2213-2017, F2119-07(2013) (MRI safety), ISO 23908 (safety shield performance), and ASTM F1980 (shelf life stability).
Substantial equivalence is established through equivalent intended use, identical indications, same manual operation, equivalent performance testing results, biocompatible materials with validated chemical characterization, and equivalent mechanical performance across safety features, needle/hub strength, catheter slider resistance, and protector fitting strength despite minor design differences that do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov