Cleared Traditional

K082512 - INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER

K082512 is an FDA 510(k) clearance for INTELLIGENT DOSING SYSTEM FOR INSULIN-M..., manufactured by Dimensional Dosing Systems, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K082512 · Dimensional Dosing Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
70d
Days
Class 2
Risk

K082512 is an FDA 510(k) clearance for the INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Dimensional Dosing Systems, Inc. (Crofton, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082512

510(k) Number K082512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2008
Decision Date November 07, 2008
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 52
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K082512.
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K081388 · Pronia Medical System, LLC · Aug 2008
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
K071713 · Medical Decisions Network · Oct 2007
ENDOTOOL DRUG DOSE CALCULATOR
K053137 · MD Scientific, LLC · Jun 2006
K082512 · INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
Download PDF FDA Summary Dimensional Dosing Sy…