Vial Vent Filter
FDA 510(k) K942275 · Gelman Sciences, Inc.
510(k) numberK942275
Submission
- Device name
- Vial Vent Filter
- Applicant
- Gelman Sciences, Inc.
Ann Arbor, MI, US - Received
- May 10, 1994
- Decision date
- July 26, 1994
- 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
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|---|---|---|---|
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| 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 |
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| 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 |
|---|---|---|
| K946190 | Drug Dispensing SpikeFMF · Traditional | 03/17/1995SE |
| K943127 | Pharmassure Large Volume Transfer FiltersFPB · Traditional | 09/29/1994SE |
| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
| K884177 | Drug Standard SetDKB · Traditional | 02/17/1989SE |
Questions and answers
When was Vial Vent Filter cleared by the FDA?
Vial Vent Filter (K942275) received a 510(k) decision of Substantially Equivalent on July 26, 1994, 77 days after the submission was received.
What is the product code of K942275?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.