Gainor Medical Flowmax Needles
FDA 510(k) K844305 · Gainor Medical
510(k) numberK844305
Submission
- Device name
- Gainor Medical Flowmax Needles
- Applicant
- Gainor Medical
- Received
- November 6, 1984
- Decision date
- November 30, 1984
- 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 |
|---|---|---|
| K850100 | Blood LancetFMK · Traditional | 01/29/1987SE |
| K850150 | Ulster Scientific, Inc. Autolet Lancets/Gainor MedFMK · Traditional | 02/21/1985SE |
| K844306 | Gainor Medical SyringeFMF · Traditional | 11/30/1984SE |
| K840951 | First Aid BandageKGX · Traditional | 10/31/1984SE |
| K840950 | Zinc Oxide TapeKGX · Traditional | 10/31/1984SE |
| K840945 | Skin ClosureFPX · Traditional | 10/31/1984SE |
| K840949 | Clear Plastic-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840947 | Cloth-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | 08/17/1984SE |
| K840948 | Clear Porous Plastic-HypoallergenicGKX · Traditional | 08/14/1984SE |
Questions and answers
When was Gainor Medical Flowmax Needles cleared by the FDA?
Gainor Medical Flowmax Needles (K844305) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 24 days after the submission was received.
What is the product code of K844305?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.