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) → FPK — Tubing, Fluid Delivery # FPK · Tubing, Fluid Delivery _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/FPK ## Overview - **Product Code:** FPK - **Device Name:** Tubing, Fluid Delivery - **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 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K131517](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K131517.md) | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | Aug 2, 2013 | SESE | | [K063114](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K063114.md) | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | Coeur, Inc. | Feb 9, 2007 | SESE | | [K063239](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K063239.md) | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | Hospira, Inc. | Dec 11, 2006 | SESE | | [K052431](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K052431.md) | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Medtronic Minimed | Nov 29, 2005 | SESE | | [K041178](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K041178.md) | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | Jul 16, 2004 | SESE | | [K031808](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K031808.md) | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | Jul 11, 2003 | SESE | | [K022431](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K022431.md) | MEDRAD TRANSFER SET | Medrad, Inc. | Sep 5, 2002 | SESE | | [K965208](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K965208.md) | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | Feb 26, 1997 | SESE | | [K953864](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K953864.md) | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | Nov 6, 1995 | SESE | | [K950508](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K950508.md) | SYSMEX SF-3000 | Sysmex Corp. | Nov 3, 1995 | SESE | | [K952243](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K952243.md) | EXTENSION SET/I.V. SET | Coast Medical, Inc. | Jul 26, 1995 | SESE | | [K952663](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K952663.md) | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP | Distronic Sterile Products, Inc. | Jul 14, 1995 | SESE | | [K950861](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K950861.md) | RECONSTITUTION ACCESSOREIS | Organon, Inc. | May 26, 1995 | SESE | | [K933524](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K933524.md) | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | May 23, 1995 | SESE | | [K950200](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K950200.md) | IVID | Scott/Ross Designs, Inc. | Mar 24, 1995 | SESE | | [K943992](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K943992.md) | SILCLEAR TUBING | Degania Silicone , Ltd. | Mar 16, 1995 | SESE | | [K943206](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K943206.md) | VARIOUS TUBING | Prn Services, Inc. | Mar 9, 1995 | SESE | | [K945184](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K945184.md) | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | Feb 8, 1995 | SESE | | [K941214](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K941214.md) | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | Oct 3, 1994 | SESE | | [K935642](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K935642.md) | EVANS MEDICAL EXTENSION SETS | Evans Medical, Inc. | Jan 28, 1994 | SESE | ## Top Applicants - Churchill Corp. — 3 clearances - Clinical Connections, Inc. — 3 clearances - 3M Company — 2 clearances - Degania Silicone , Ltd. — 2 clearances - Distronic Sterile Products, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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