FPB · Filter, Infusion Line
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | FPB |
|---|---|
| Device Name | Filter, Infusion Line |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Classification Rationale
Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 98)
Showing 20 most recent of 98 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | May 10, 2024 | SESE |
| K143583 | Cathivex ¿GV filter units | Merck Millipore , Ltd. | Aug 11, 2015 | SESE |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Baxter Healthcare Corp | Dec 8, 2011 | SESE |
| K021293 | ARTERIA BLOOD FILTER | Arteria Medical Science, Inc. | Aug 22, 2002 | SESE |
| K993379 | PALL SUPOR AEF FILTER | Pall Corp. | Dec 16, 1999 | SESE |
| K974661 | 0.2 U BACTERIAL FILTER | Sims Deltec, Inc. | Feb 11, 1998 | SESE |
| K964283 | AUTOPRIME | Arbor Technologies, Inc. | Jan 22, 1997 | SESE |
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | Jan 9, 1997 | SESE |
| K933523 | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | May 19, 1995 | SESE |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | Feb 16, 1995 | SESE |
| K942625 | 1.2 MICRON AIR ELIMINATING FILTER | The Medi-Dose Group | Oct 7, 1994 | SESE |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | Sep 29, 1994 | SESE |
| K942532 | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | Aug 17, 1994 | SESE |
| K941684 | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE | Abbott Laboratories | Aug 3, 1994 | SESE |
| K942275 | VIAL VENT FILTER | Gelman Sciences, Inc. | Jul 26, 1994 | SESE |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | Jul 14, 1994 | SESE |
| K933869 | EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER | Baxter Healthcare Corp | Apr 26, 1994 | SESE |
| K940293 | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE | Puritas Health Care, Inc. | Mar 28, 1994 | SESE |
| K933294 | MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES | Aesculap, Inc. | Feb 9, 1994 | SESE |
| K935641 | 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS | Evans Medical, Inc. | Jan 28, 1994 | SESE |
Top Applicants
- Abbott Laboratories — 11 clearances
- Tri-Med, Inc. — 8 clearances
- Pall Biomedical Products Co. — 7 clearances
- Alltek, Inc. — 4 clearances
- Baxter Healthcare Corp — 4 clearances
