510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031419Substantially Equivalent

Gri-Flex, Models 1000Ml, 500Ml, 250Ml, 100Ml

Laboratorios Grifols, S.A., Parets Del Valles, Barcelona, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031419 is the FDA 510(k) clearance record for GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML, a class II device, cleared for Laboratorios Grifols, S.A. on under FDA product code KPE (Container, I.V.). FDA records list 9 510(k) clearances for Laboratorios Grifols, S.A., from to . As of , FDA records show no recalls naming K031419.

Clearance record

Decision date
Received
(203 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Laboratorios Grifols, S.A. Pol. Levante C/Can Guasch, 2, Parets Del Valles, Barcelona, ES
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KPE

Trailing 12 months
3 clearances under product code KPE in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260