Cleared Traditional

K212530 - IVX Fluid Transfer Set

K212530 is an FDA 510(k) clearance for IVX Fluid Transfer Set, manufactured by Omnicell, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K212530 · Omnicell, Inc. · General Hospital
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Apr 2022
Decision
256d
Days
Class 2
Risk

K212530 is an FDA 510(k) clearance for the IVX Fluid Transfer Set. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Omnicell, Inc. (Cranberry, US). The FDA issued a Cleared decision on April 24, 2022 after a review of 256 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Omnicell, Inc. devices

FDA 510(k) Submission Details - K212530

510(k) Number K212530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2021
Decision Date April 24, 2022
Days to Decision 256 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 129d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 74
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