Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
FDA 510(k) K073257 · Kawasumi Laboratories, Inc.
510(k) numberK073257
Submission
- Device name
- Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
- Applicant
- Kawasumi Laboratories, Inc.
Tampa, FL, US - Received
- November 19, 2007
- Decision date
- January 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| 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 |
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| 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 |
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| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA · Traditional | 07/08/2019SE |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS)FPA · Special | 05/02/2019SE |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | 09/28/2018SE |
| K123344 | K-Shield Advantage Port Access Infusion Set (Pais)FPA · Traditional | 03/07/2013SE |
| K100720 | K-Shield Port Access Infusion Set with High Pressure TubingFPA · Traditional | 11/18/2010SE |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorFMI · Special | 11/03/2010SE |
| K061197 | Kawasumi Laboratories Empty Solution ContainerKPE · Traditional | 06/30/2006SE |
| K060580 | K-Shield Port Access Infusion SetFPA · Traditional | 06/06/2006SE |
| K023917 | Winged Needle Sets with an Antineedle Stick ProtectorFPA · Traditional | 02/26/2003SE |
| K022110 | Kawasumi Laboratories Antineedle Stick Protector for Use with Port Access Infusion Sets.LJT · Traditional | 09/12/2002SE |
Questions and answers
When was Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector cleared by the FDA?
Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (K073257) received a 510(k) decision of Substantially Equivalent on January 25, 2008, 67 days after the submission was received.
What is the product code of K073257?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.