Product code FPK— General Hospital
ANESTHESIA EXTENSION TUBES
- Classification name
- Tubing, Fluid Delivery
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Total cleared
- 64
- First cleared
- Most recent
Market context for product code FPK
FDA has cleared devices under product code FPK between 1977 and 2013, filed by 54 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1989
- 1988
Top applicants under product code FPK
Recent clearances under product code FPK
- K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
- K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
- K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
- K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)
- K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET
- K022431 — MEDRAD TRANSFER SET
- K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128
- K953864 — SILCLEAR TUBING (MODIFICATION)
- K950508 — SYSMEX SF-3000
- K952243 — EXTENSION SET/I.V. SET
- K952663 — 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP
- K950861 — RECONSTITUTION ACCESSOREIS
- K933524 — EXTENTION SET
- K950200 — IVID
- K943992 — SILCLEAR TUBING
- K943206 — VARIOUS TUBING
- K945184 — INTRAVASCULAR ADMINISTRATION SET
- K941214 — LIFESHIELD EXTENSION SET
- K935642 — EVANS MEDICAL EXTENSION SETS
- K921450 — NON-INVASIVE TUBING
- K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS
- K915560 — LO-PROFILE EXTENSION SET
- K912103 — LIFESHIELD EXTENSION SET
- K910906 — CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
- K891009 — INTRAVASCULAR ADMINISTRATION SET MODEL 60040
- K891005 — INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
- K883718 — MERIT HI-FLEX(TM)
- K884156 — HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
- K884370 — CMS IV EXTENSION SETS
- K875186 — IV EXTENSION SET
- K873465 — VAN DELLEN BACTERIA FILTER
- K873852 — INFUSION MANIFOLD
- K874360 — PLASTIC TUBING CONNECTOR
- K871085 — EXTENSION TUBE PUMP SET
- K871540 — SWIVEL CONNECTORS #014452/#014453/#014459-120
- K870416 — LP EXTENSION SETS
- K870912 — T-CONNECTORS 014500/014501/014502/014503-120
- K870326 — VARIOUS LUER AND TUBING FITTINGS
- K864692 — EXTENSION SETS
- K864395 — LOW VOLUME EXTENSION SET
- K861626 — CHURCHILL EXTENSION TUBE
- K854629 — CHURCHILL-H EXTENSION TUBE
- K834164 — SPINAL NEEDLES & ACCESSORY
- K833659 — IV EXTENSION SET
- K833076 — C-FLEX MEDICAL GRADE TUBING
- K832758 — RED COLOR-TINTED TUBING
- K820527 — ANESTHESIA EXTENSION TUBES
- K812981 — FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
- K811847 — SEA MEDICAL PRODUCTS LO-VOL
- K810005 — SAFEED EXTENSION TUBES
- K800877 — ANESTHESIA EXTENSION TUBES
- K800879 — CLEAR PLASTIC CONNECTING TUBES
- K800825 — EXTENSION SET QUEST CODE #3000
- K781087 — MEDICAL GRADE SILICONE ELASTOMER TUBING
- K780673 — CENTRAL CATHETER KIT
- K780396 — NASAL GASTRIC TUBE RETAINER
- K772119 — TIME WATCH
- K771269 — BLOOD COLLECTION SET TYPE H
- K771387 — MONITORING LINES & FLUID ADMIN.
- K770945 — POUCH, TYVEK-POLYMYLON
- K770596 — CONNECTORS
- K770174 — LUER-LOCK EXTENSION SET
- K770108 — TUBE HOLDING DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.