Cleared Traditional

K854249 - COMPUTER ASSISTED DIABETIC INTRUCTION

K854249 is an FDA 510(k) clearance for COMPUTER ASSISTED DIABETIC INTRUCTION, manufactured by Applied Biomedical Computations, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K854249 · Applied Biomedical Computations, Inc. · General Hospital
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Mar 1986
Decision
156d
Days
Class 2
Risk

K854249 is an FDA 510(k) clearance for the COMPUTER ASSISTED DIABETIC INTRUCTION. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Applied Biomedical Computations, Inc. (Washington, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 156 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 Applied Biomedical Computations, Inc. devices

FDA 510(k) Submission Details - K854249

510(k) Number K854249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1985
Decision Date March 27, 1986
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
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

All 51
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K854249.
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ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · Abbott Laboratories · Jan 1986