Cleared Traditional

K163664 - Health-e-Connect System with IDA

K163664 is an FDA 510(k) clearance for Health-e-Connect System with IDA, manufactured by Alr Technologies. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K163664 · Alr Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
265d
Days
Class 2
Risk

K163664 is an FDA 510(k) clearance for the Health-e-Connect System with IDA. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Alr Technologies (North Chesterfield, US). The FDA issued a Cleared decision on September 18, 2017 after a review of 265 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 Alr Technologies devices

FDA 510(k) Submission Details - K163664

510(k) Number K163664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date September 18, 2017
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
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 Peers - NDC Calculator, Drug Dose

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