Medline Blood Collection Set
FDA 510(k) K170002 · Medline Industries, Inc.
510(k) numberK170002
Submission
- Device name
- Medline Blood Collection Set
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- January 3, 2017
- Decision date
- September 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
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Questions and answers
When was Medline Blood Collection Set cleared by the FDA?
Medline Blood Collection Set (K170002) received a 510(k) decision of Substantially Equivalent on September 19, 2017, 259 days after the submission was received.
What is the product code of K170002?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.