IV Start Kit
FDA 510(k) K953474 · Medikmark, Inc.
510(k) numberK953474
Submission
- Device name
- IV Start Kit
- Applicant
- Medikmark, Inc.
Buffalo Grove, IL, US - Received
- July 24, 1995
- Decision date
- October 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923960 | Upper Extermity Drape KitKKX · Traditional | 10/07/1994SE |
| K921733 | Tracheostomy Care TrayJOH · Traditional | 06/15/1994SESK |
| K921732 | Minor Lap SetKOH · Traditional | 06/15/1994SE |
| K921730 | C-Section PackKOH · Traditional | 06/15/1994SE |
| K920341 | Laceration TraysKKX · Traditional | 04/23/1992SEKD |
| K920340 | Suture Removal KitKKX · Traditional | 04/23/1992SEKD |
| K920339 | Dressing Change TrayFRG · Traditional | 04/23/1992SEKD |
Questions and answers
When was IV Start Kit cleared by the FDA?
IV Start Kit (K953474) received a 510(k) decision of Substantially Equivalent on October 2, 1995, 70 days after the submission was received.
What is the product code of K953474?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.