Gent-L-Kare Sterile I.V. Start Kit
FDA 510(k) K844255 · Geneva Laboratories, Inc.
510(k) numberK844255
Submission
- Device name
- Gent-L-Kare Sterile I.V. Start Kit
- Applicant
- Geneva Laboratories, Inc.
Elkhorn, WI, US - Received
- November 2, 1984
- Decision date
- December 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| 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 |
|---|---|---|
| K881217 | Gent-L-Kare Sterile Urinary Leg BagKNX · Traditional | 07/29/1988SE |
| K881218 | Gent-L-Kare Cleansing Enema SetFCE · Traditional | 07/28/1988SE |
| K881213 | Gent-L-Kare Sterile Urinary Drainage Bag CenterKNX · Traditional | 07/28/1988SE |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | 06/07/1988SE |
| K861308 | Accupac Custom Pack Kerlix SquaresEFQ · Traditional | 05/02/1986SE |
| K861219 | Accupac Custom Skin Scrub Kit · Traditional | 04/15/1986SE |
| K853265 | Accupac Custom Operating Room PROCEDURE-DK876543 · Traditional | 08/26/1985SE |
| K843206 | Cook County Hospital Dressing Change SetKDD · Traditional | 05/24/1985SE |
| K843090 | University of Chicago Vascular AngiogramFPA · Traditional | 12/04/1984SE |
| K830725 | Gent-L-Spec Dispos. Vaginal SpeculumHIB · Traditional | 04/27/1983SE |
Questions and answers
When was Gent-L-Kare Sterile I.V. Start Kit cleared by the FDA?
Gent-L-Kare Sterile I.V. Start Kit (K844255) received a 510(k) decision of Substantially Equivalent on December 19, 1984, 47 days after the submission was received.
What is the product code of K844255?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.