Cleared Traditional

K181916 - d-Nav System (FDA 510(k) Clearance)

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

K181916 · Hygieia, Inc. · General Hospital
Feb 2019
Decision
202d
Days
Class 2
Risk

K181916 is an FDA 510(k) clearance for the d-Nav System. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Hygieia, Inc. (Livonia, US). The FDA issued a Cleared decision on February 4, 2019 after a review of 202 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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.

Submission Details

510(k) Number K181916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2018
Decision Date February 04, 2019
Days to Decision 202 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 169d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.