Cleared Traditional

K192860 - Sapphire Infusion Pump

K192860 is the FDA 510(k) clearance for Sapphire Infusion Pump by Q Core Medical , Ltd.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K192860 · Q Core Medical , Ltd. · General Hospital
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Nov 2020
Decision
412d
Days
Class 2
Risk

K192860 is an FDA 510(k) clearance for the Sapphire Infusion Pump, Sapphire administration sets. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Q Core Medical , Ltd. (Netanya, IL). The FDA issued a Cleared decision on November 19, 2020 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Q Core Medical , Ltd. devices

Submission Details

510(k) Number K192860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2019
Decision Date November 19, 2020
Days to Decision 412 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
283d slower than avg
Panel avg: 129d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Consultant

Z&B Enterprises, Inc.
Rhona Shanker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 433
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