Cleared Abbreviated

K162216 - GRI-FILL PERISTALTIC SET

K162216 is an FDA 510(k) clearance for GRI-FILL PERISTALTIC SET, manufactured by Laboratorios Grifols, S.A.. The device is a Class 2 General Hospital device with product code LHI cleared through the Abbreviated 510(k) pathway after a 437-day FDA review.

K162216 · Laboratorios Grifols, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
437d
Days
Class 2
Risk

K162216 is an FDA 510(k) clearance for the GRI-FILL PERISTALTIC SET. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Laboratorios Grifols, S.A. (Parets Del Valles,, ES). The FDA issued a Cleared decision on October 19, 2017 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Laboratorios Grifols, S.A. devices

FDA 510(k) Submission Details - K162216

510(k) Number K162216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date October 19, 2017
Days to Decision 437 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 129d · This submission: 437d
Pathway characteristics
Standards-based clearance path.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 79
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K162216.
Vial Adapter Ø20 mm
K190149 · Avenir Performance Europeenne Medical (Apem) · Oct 2019
nextaro Transfer System, nextaro va
K183187 · Sfm Medical Devices GmbH · Mar 2019
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014