K092246 is an FDA 510(k) clearance for the NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on November 12, 2009, 107 days after receiving the submission on July 28, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K092246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2009 |
| Decision Date | November 12, 2009 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |