Cleared Traditional

K170110 - Diana Medication Transfer Set (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170110 · Icu Medical, Inc. · General Hospital
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Aug 2018
Decision
575d
Days
Class 2
Risk

K170110 is an FDA 510(k) clearance for the Diana Medication Transfer Set. Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 10, 2018 after a review of 575 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K170110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date August 10, 2018
Days to Decision 575 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
447d slower than avg
Panel avg: 128d · This submission: 575d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.
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 - ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

All 40
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