Cleared Traditional

K160949 - Go Dose System

K160949 is an FDA 510(k) clearance for Go Dose System, manufactured by Eli Lilly and Company. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K160949 · Eli Lilly and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
261d
Days
Class 2
Risk

K160949 is an FDA 510(k) clearance for the Go Dose System. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 261 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.

View all Eli Lilly and Company devices

FDA 510(k) Submission Details - K160949

510(k) Number K160949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date December 22, 2016
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

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.

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