Fast Flow XX (Aqueous Solution Filter)
FDA 510(k) K860372 · Healthtek, Inc.
510(k) numberK860372
Submission
- Device name
- Fast Flow XX (Aqueous Solution Filter)
- Applicant
- Healthtek, Inc.
Nevada City, CA, US - Received
- February 3, 1986
- Decision date
- May 30, 1986
- 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 |
|---|---|---|
| K923448 | Empty Solution Transfer Container W/ Detach LegKPE · Traditional | 07/28/1993SE |
| K913985 | Transfer-Aid(Tm)LHI · Traditional | 03/18/1992SE |
| K913608 | SnapperKPE · Traditional | 11/29/1991SE |
| K881590 | Adfuse(Tm)FRN · Traditional | 05/23/1988SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | 02/16/1988SE |
| K873848 | Retrobulbar NeedleGDM · Traditional | 10/23/1987SE |
| K860610 | AdcompLHI · Traditional | 07/08/1986SE |
| K854008 | StatlockLHI · Traditional | 11/13/1985SE |
Questions and answers
When was Fast Flow XX (Aqueous Solution Filter) cleared by the FDA?
Fast Flow XX (Aqueous Solution Filter) (K860372) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 116 days after the submission was received.
What is the product code of K860372?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.