Filter, I.V. (#4700)
FDA 510(k) K760110 · Jelco Laboratories
510(k) numberK760110
Submission
- Device name
- Filter, I.V. (#4700)
- Applicant
- Jelco Laboratories
Mchenry, IL, US - Received
- June 24, 1976
- Decision date
- July 16, 1976
- 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
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K791918 | Jelco Winged Intravascular CatheterFOZ · Traditional | 10/02/1979SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | 09/12/1979SE |
| K790967 | Catheter Metal Hub/RadiopaqueFOZ · Traditional | 06/27/1979SE |
| K790968 | Catheter Metal Hub/NonradiopaqueFOZ · Traditional | 06/11/1979SE |
| K790471 | Jelco* Disc FILTER-0.2 MicronFPB · Traditional | 04/30/1979SE |
| K790186 | ProtectivstabilizerGBJ · Traditional | 02/26/1979SE |
| K790107 | Catheter Tubing ModificationDQO · Traditional | 02/01/1979SE |
| K790079 | Needle, Blood CollectingGAA · Traditional | 02/01/1979SE |
| K781857 | Tray, Arterial Blood Gas SamplingCBT · Traditional | 12/11/1978SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | 08/23/1978SE |
Questions and answers
When was Filter, I.V. (#4700) cleared by the FDA?
Filter, I.V. (#4700) (K760110) received a 510(k) decision of Substantially Equivalent on July 16, 1976, 22 days after the submission was received.
What is the product code of K760110?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.