Harmac Huber Needle Safety Device, H2984001
FDA 510(k) K021916 · Harmac Medical Products, Inc.
510(k) numberK021916
Submission
- Device name
- Harmac Huber Needle Safety Device, H2984001
- Applicant
- Harmac Medical Products, Inc.
Buffalo, NY, US - Received
- June 11, 2002
- Decision date
- August 29, 2002
- 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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| 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 |
|---|---|---|
| K963335 | Harmac Balloon Wedge Pressure CatheterDQO · Traditional | 10/16/1997SE |
| K962829 | Harmac Balloon Angiographic CatheterDQO · Traditional | 10/16/1997SE |
| K962833 | Harmac Temporary Pacing Catheter with BalloonLDF · Traditional | 10/15/1997SE |
| K963336 | Harmac Thermodilution CatheterDYG · Traditional | 08/14/1997SE |
| K963073 | Harmac Bipolar Temporary Pacing Catheter with StyletLDF · Traditional | 08/14/1997SE |
| K963074 | Harmac Quadpolar Mapping Pacing CatheterDRF · Traditional | 06/25/1997SE |
| K950895 | Harmac Extension Infusion SetFPA · Traditional | 09/01/1995SE |
Questions and answers
When was Harmac Huber Needle Safety Device, H2984001 cleared by the FDA?
Harmac Huber Needle Safety Device, H2984001 (K021916) received a 510(k) decision of Substantially Equivalent on August 29, 2002, 79 days after the submission was received.
What is the product code of K021916?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.