Product code KPE— General Hospital
BAG DECANTER
- Classification name
- Container, I.V.
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Total cleared
- 117
- First cleared
- Most recent
Market context for product code KPE
FDA has cleared devices under product code KPE between 1976 and 2026, filed by 72 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- 2026
- 2025
- 2024
- 2023
- 2021
- 2020
- 2019
- 2013
- 2012
- 2011
- 2009
- 2008
- 2006
- 2004
- 2003
Top applicants under product code KPE
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KPE
1–100 of 117- K252079 — Disposable Infusion Bag for Parenteral Nutrition
- K251980 — ClaveQS Bag
- K251139 — KabiHelp® Uno; KabiHelp® Advance plus
- K252094 — eZSURE Empty Fluid Container
- K250459 — DMRX 100ml Empty Container Solution +3 more
- K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site
- K223674 — eZSURE Empty Fluid Container (models 426030, 426040, 426110)
- K222622 — Disposable Infusion Bag for Parenteral Nutrition
- K210749 — Empty EVA Bag
- K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
- K193528 — Empty EVA Bag
- K190328 — HCT Empty EVA Container Pack
- K190305 — Additive Cap
- K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
- K132276 — STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
- K121161 — EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
- K111217 — ADDITIVE CAP
- K101412 — EVA TPN BAG
- K090096 — ALL-IN-ONE CONTAINER
- K073538 — DUAL CHAMBER TPN CONTAINER
- K061197 — KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K041415 — EVA TPN CONTAINER
- K033916 — GRI-BAG, GRI-BAG AP
- K031419 — GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
- K030888 — EVA EMPTY SOLUTION CONTAINER
- K020485 — ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
- K001461 — TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
- K001287 — EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- K983294 — ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
- K982048 — MPS RESERVOIR BAG
- K974180 — STERI-TAMP
- K973103 — CHARTERMED TPN-EVA BAGS
- K972464 — VITALMIX PLUS EMPTY I.V. CONTAINER
- K964853 — INTRAVIA CONTAINER, EMPTY
- K960581 — SECURE EVA DUAL CHAMBER MIXING BAG
- K945193 — ALL-IN-ONE TWO CHAMBER CONTAINER
- K941731 — EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
- K932477 — UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
- K934179 — DISPOSABLE BAG DECANTER
- K940258 — SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)
- K932649 — PHARMAFEED
- K932640 — EVA EMPTY MIXING CONTAINER
- K932641 — EMPTY MIXING CONTAINER
- K926123 — DUAL CHAMBER MIXING BAG
- K923448 — EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG
- K922214 — EMPTY VIAFLEX PLASTIC CONTAINER
- K913608 — SNAPPER
- K911567 — DUAL COMPARTMENT TPN BAG 3 LITER
- K910936 — EMPTY I.V. CONTAINER
- K911576 — CHEMOTHERAPY CONTAINER
- K910673 — BAG SPIGOT
- K902079 — ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION
- K902464 — CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY
- K895924 — METRICARE DRUG RESERVOIRS
- K883400 — OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
- K885173 — MIX CONTAINER W/ATTACHED TRANSFER SET
- K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
- K890095 — PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
- K891077 — MEDIVERSE PARENTERAL NUTRITION BAG
- K890268 — PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION
- K890272 — BAG DECANTER
- K880506 — MODIFIED EVA-MIX AND DI-MIX BAGS
- K875155 — 60 ML RESERVOIR BAG, ITEM #200
- K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA
- K871449 — ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
- K870052 — INFUMIX MIXING CONTAINER
- K870113 — THERMAL JACKET FOR I.V. FLUID BAGS
- K870274 — DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER
- K863040 — DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
- K860042 — NUTRIMIX EMPTY CONTAINER
- K854031 — SNAP-LOCK ADDITIVE CAP #SL100
- K854033 — SNAP-LOCK ADDITIVE CAP #SL400
- K854034 — SNAP-LOCK ADDITIVE CAP #SL 300
- K854032 — SNAP-LOCK ADDITIVE CAP #SL 200
- K852938 — TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
- K852893 — VIAL DECANTER
- K852777 — BAG DECANTER
- K852778 — BOTTLE DECANTER
- K850035 — EMPTY SOLUTION TRANSFER CONTAINER
- K844664 — THE I.V. BAG
- K844077 — NUTRIMIX EMPTY CONTAINER
- K843954 — MIXING CONTAINER
- K844410 — NUTRIBAG MIXING CONTAINER -2000 ML
- K841597 — GIL-MED PARENTERAL NUTRITION OR MEDICINE
- K842170 — EMPTY SOLUTION TRANSFER CONTAINER
- K843523 — EMPTY SOLUTION TRANSFER CONTAINER 1000
- K842628 — HOME NUTRIBAG MIXING CONTAINER 1000ML
- K842629 — HOME NUTRIBAG MIXING CONTAINER 3000ML
- K840915 — DIMIX CONTAINER FOR PARNETERAL NUTRIT
- K840388 — PAB IV CONTAINER
- K832247 — I.V. BAG ADDISEAL
- K832254 — BAXA ADDISEAL
- K830193 — CAT 3040
- K830450 — DELMED IV CONTAINER
- K830299 — SOLUTION TRANSFER CONTAINER
- K830232 — DECANTER MODELS-VARIOUS
- K823538 — POUR BOTTLE DECANTER #2010
- K820200 — IV ALERT SYSTEM
- K820435 — BAXA ADDISEAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.