Home / 510(k) Clearances / K101412

510(k) K101412

EVA TPN BAG by Valmed S.R.L. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2011
Date Received
May 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Valmed S.R.L.

  • K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM (February 15, 2019)
  • K112148 — POWERED MUSCLE STIMULATOR (April 30, 2012)
  • K031611 — P4-FITNESS (September 29, 2004)
  • K022175 — P4 PHYSIO (September 9, 2002)
  • K010754 — NURSE'S ASSISTANT O.R. CONTROL SYSTEM (August 15, 2001)
  • K010716 — VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML60 (May 30, 2001)
  • K925336 — VALU-PLUS PAD (February 12, 1993)

Other clearances for product code KPE

  • K251139 — KabiHelp® Uno; KabiHelp® Advance plus (January 9, 2026)
  • K252094 — eZSURE™ Empty Fluid Container (August 1, 2025)
  • K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 5 (April 18, 2025)
  • K241442 — eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (June 21, 2024)
  • K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (September 1, 2023)
  • K222622 — Disposable Infusion Bag for Parenteral Nutrition (February 16, 2023)
  • K210749 — Empty EVA Bag (August 19, 2021)
  • K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)
  • K193528 — Empty EVA Bag (July 22, 2020)
  • K190328 — HCT Empty EVA Container Pack (August 15, 2019)