FPK · Tubing, Fluid Delivery
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | FPK |
|---|---|
| Device Name | Tubing, Fluid Delivery |
| 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 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | Aug 2, 2013 | SESE |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | Coeur, Inc. | Feb 9, 2007 | SESE |
| K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | Hospira, Inc. | Dec 11, 2006 | SESE |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Medtronic Minimed | Nov 29, 2005 | SESE |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | Jul 16, 2004 | SESE |
| K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | Jul 11, 2003 | SESE |
| K022431 | MEDRAD TRANSFER SET | Medrad, Inc. | Sep 5, 2002 | SESE |
| K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | Feb 26, 1997 | SESE |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | Nov 6, 1995 | SESE |
| K950508 | SYSMEX SF-3000 | Sysmex Corp. | Nov 3, 1995 | SESE |
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | Jul 26, 1995 | SESE |
| K952663 | 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 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | May 26, 1995 | SESE |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | May 23, 1995 | SESE |
| K950200 | IVID | Scott/Ross Designs, Inc. | Mar 24, 1995 | SESE |
| K943992 | SILCLEAR TUBING | Degania Silicone , Ltd. | Mar 16, 1995 | SESE |
| K943206 | VARIOUS TUBING | Prn Services, Inc. | Mar 9, 1995 | SESE |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | Feb 8, 1995 | SESE |
| K941214 | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | Oct 3, 1994 | SESE |
| K935642 | 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
