510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FPKClass II

Tubing, Fluid Delivery

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

FPK is the FDA product code for Tubing, Fluid Delivery, a class II device type, regulated under 21 CFR 880.5440. As of , FDA records hold 64 510(k) clearances under this code, the most recent dated , and 28 recalls.

Classification record

Product code
FPK
Device name
Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
64
Ingested recalls
28

Clearances, product code FPK

By decision year
64 clearances under product code FPK with a decision year between 1977 and 2013, 1995 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code FPK by decision year
YearClearances
19777
19783
19803
19813
19821
19834
19851
19863
19877
19884
19893
19912
19922
19931
19942
199510
19971
20021
20031
20041
20051
20061
20071
20131

Applicants with the most clearances

Product code FPK
Applicants holding the most 510(k) clearances under product code FPK
ApplicantClearances
Churchill Corp.3
Clinical Connections, Inc.3
3M Company2
Abbott Medical2
Degania Silicone, Inc.2
Distronic Sterile Products, Inc.2
Harvard Laboratories2
Medrad, Inc.2
Medtronic, Inc.2
Abbott Mfg., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order