UltraFlo-R Push Button Blood Collection Set
FDA 510(k) K220458 · Innovative Medical Technologies, Inc.
510(k) numberK220458
Submission
- Device name
- UltraFlo-R Push Button Blood Collection Set
- Applicant
- Innovative Medical Technologies, Inc.
Omaha, NE, US - Received
- February 17, 2022
- Decision date
- September 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
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| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
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| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123987 | Improve Blood Collection Set and Improsafe Blood Collection SetJKA · Traditional | 08/27/2013SE |
| K972969 | Quick-Draw Capillary Whole Blood Collection SystemGIO · Traditional | 09/22/1997SE |
| K936087 | Carpal BoxKPR · Traditional | 10/20/1994SE |
| K904237 | Rapid Immobilization Device or R.I.D. SystemFPP · Traditional | 05/09/1991SE |
| K854194 | Imt Ultrasonic Stride Monitor · Traditional | 05/02/1986SE |
Questions and answers
When was UltraFlo-R Push Button Blood Collection Set cleared by the FDA?
UltraFlo-R Push Button Blood Collection Set (K220458) received a 510(k) decision of Substantially Equivalent on September 29, 2023, 589 days after the submission was received.
What is the product code of K220458?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.