40 Micron Blood Transfusion Filter
FDA 510(k) K941628 · Douglas Medical Products Corp.
510(k) numberK941628
Submission
- Device name
- 40 Micron Blood Transfusion Filter
- Applicant
- Douglas Medical Products Corp.
Mundelein, IL, US - Received
- April 4, 1994
- Decision date
- February 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K162951 | TUBETECH IV Administration SetFPA · Traditional | 07/28/2017SE |
| K961155 | Solo Picc/Midline Catheter Kit Models 71924, 71908LJS · Traditional | 06/18/1996SE |
| K954428 | Solopicc 24 (60CM) 20GA CatheterFOZ · Traditional | 03/28/1996SE |
| K942101 | 4-LEAD Irrigation SetHRX · Traditional | 09/30/1994SE |
| K941453 | Check Valve Solution SetFPA · Traditional | 08/16/1994SE |
| K930854 | Solution Set with .2 Micron FilterFPA · Traditional | 01/14/1994SE |
| K932637 | Subcutaneous Infusion SetFPA · Traditional | 01/07/1994SE |
| K931659 | 3 Lead ConnectorFPA · Traditional | 01/07/1994SE |
| K931658 | In-Line Burette SetFPA · Traditional | 12/21/1993SE |
| K932638 | Huber Needle Infusion SetFPA · Traditional | 12/14/1993SE |
Questions and answers
When was 40 Micron Blood Transfusion Filter cleared by the FDA?
40 Micron Blood Transfusion Filter (K941628) received a 510(k) decision of Substantially Equivalent on February 16, 1995, 318 days after the submission was received.
What is the product code of K941628?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.