Autoprime
FDA 510(k) K964283 · Arbor Technologies, Inc.
510(k) numberK964283
Submission
- Device name
- Autoprime
- Applicant
- Arbor Technologies, Inc.
Ann Arbor, MI, US - Received
- October 28, 1996
- Decision date
- January 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K941628 | 40 Micron Blood Transfusion FilterFPB · Traditional | Douglas Medical Products Corp. | 02/16/1995SE |
More from Douglas Medical Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960928 | SyringefilterBSN · Traditional | 04/04/1997SE |
| K922777 | Pressure Tubing and AccessoriesHIF · Traditional | 03/22/1994SE |
| K902666 | Anesthesia Conduction FilterBSN · Traditional | 04/23/1991SE |
| K895859 | Contain(Tm)GCX · Traditional | 02/07/1991SE |
| K902167 | Contain(Tm) Laser Plume FilterJDY · Traditional | 01/04/1991SE |
| K890844 | Microsept 60/20CAK · Traditional | 06/07/1989SE |
| K874505 | Contain(Tm)GCX · Traditional | 05/20/1988SE |
| K864113 | Clyde (TM) Filtration SystemFPB · Traditional | 02/04/1987SE |
| K863162 | Vacu-Guard · Traditional | 08/29/1986SE |
Questions and answers
When was Autoprime cleared by the FDA?
Autoprime (K964283) received a 510(k) decision of Substantially Equivalent on January 22, 1997, 86 days after the submission was received.
What is the product code of K964283?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.