Cleared Traditional

K160673 - Insulin Algorithms System

K160673 is an FDA 510(k) clearance for Insulin Algorithms System, manufactured by Insulin Algorithms. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K160673 · Insulin Algorithms · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
454d
Days
Class 2
Risk

K160673 is an FDA 510(k) clearance for the Insulin Algorithms System. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Insulin Algorithms (Los Angeles, US). The FDA issued a Cleared decision on June 7, 2017 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

FDA 510(k) Submission Details - K160673

510(k) Number K160673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2016
Decision Date June 07, 2017
Days to Decision 454 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
325d slower than avg
Panel avg: 129d · This submission: 454d
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.

Regulatory Consultant

Medtech Consultants, Inc.
Sigi Caron

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 - NDC Calculator, Drug Dose

All 52
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K160673 · Insulin Algorithms System
Download PDF FDA Summary Insulin Algorithms