Jelco* Disc FILTER-0.2 Micron
FDA 510(k) K790471 · Jelco Laboratories
510(k) numberK790471
Submission
- Device name
- Jelco* Disc FILTER-0.2 Micron
- Applicant
- Jelco Laboratories
Walker, MI, US - Received
- March 5, 1979
- Decision date
- April 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A…FPB · Traditional | Global Life Sciences Solutions USA, LLC | 08/31/2026SE |
| K233277 | Filter Needle for Single UseFPB · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 05/10/2024SE |
| K143583 | Cathivex ¿GV filter unitsFPB · Traditional | Merck Millipore , Ltd. | 08/11/2015SE |
| K113227 | Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterFPB · Special | Baxter Healthcare Corp | 12/08/2011SE |
| K021293 | Arteria Blood FilterFPB · Traditional | Arteria Medical Science, Inc. | 08/22/2002SE |
| K993379 | Pall Supor Aef FilterFPB · Traditional | Pall Corp. | 12/16/1999SE |
| K974661 | 0.2 U Bacterial FilterFPB · Traditional | Sims Deltec, Inc. | 02/11/1998SE |
| K964283 | AutoprimeFPB · Traditional | Arbor Technologies, Inc. | 01/22/1997SE |
| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | Pall Biomedical Products Co. | 01/09/1997SE |
| K933523 | I.V. Filter SetFPB · Traditional | Mediziv Medical Products 1987 , Ltd. | 05/19/1995SE |
More from Mediziv Medical Products 1987 , Ltd.
| 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 |
| 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 |
| K780519 | Filter TubeBSN · Traditional | 05/09/1978SE |
Questions and answers
When was Jelco* Disc FILTER-0.2 Micron cleared by the FDA?
Jelco* Disc FILTER-0.2 Micron (K790471) received a 510(k) decision of Substantially Equivalent on April 30, 1979, 56 days after the submission was received.
What is the product code of K790471?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.