Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → FPB — Filter, Infusion Line # FPB · Filter, Infusion Line _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB ## Overview - **Product Code:** FPB - **Device Name:** Filter, Infusion Line - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K233277.md) | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | May 10, 2024 | SESE | | [K143583](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K143583.md) | Cathivex ¿GV filter units | Merck Millipore , Ltd. | Aug 11, 2015 | SESE | | [K113227](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K113227.md) | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Baxter Healthcare Corp | Dec 8, 2011 | SESE | | [K021293](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K021293.md) | ARTERIA BLOOD FILTER | Arteria Medical Science, Inc. | Aug 22, 2002 | SESE | | [K993379](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K993379.md) | PALL SUPOR AEF FILTER | Pall Corp. | Dec 16, 1999 | SESE | | [K974661](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K974661.md) | 0.2 U BACTERIAL FILTER | Sims Deltec, Inc. | Feb 11, 1998 | SESE | | [K964283](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K964283.md) | AUTOPRIME | Arbor Technologies, Inc. | Jan 22, 1997 | SESE | | [K954331](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K954331.md) | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | Jan 9, 1997 | SESE | | [K933523](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K933523.md) | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | May 19, 1995 | SESE | | [K941628](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K941628.md) | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | Feb 16, 1995 | SESE | | [K942625](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K942625.md) | 1.2 MICRON AIR ELIMINATING FILTER | The Medi-Dose Group | Oct 7, 1994 | SESE | | [K943127](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K943127.md) | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | Sep 29, 1994 | SESE | | [K942532](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K942532.md) | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | Aug 17, 1994 | SESE | | [K941684](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K941684.md) | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE | Abbott Laboratories | Aug 3, 1994 | SESE | | [K942275](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K942275.md) | VIAL VENT FILTER | Gelman Sciences, Inc. | Jul 26, 1994 | SESE | | [K940980](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K940980.md) | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | Jul 14, 1994 | SESE | | [K933869](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K933869.md) | EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER | Baxter Healthcare Corp | Apr 26, 1994 | SESE | | [K940293](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K940293.md) | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE | Puritas Health Care, Inc. | Mar 28, 1994 | SESE | | [K933294](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K933294.md) | MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES | Aesculap, Inc. | Feb 9, 1994 | SESE | | [K935641](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K935641.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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