Cleared Traditional

K061110 - GLUCOMMANDER PLUS

K061110 is an FDA 510(k) clearance for GLUCOMMANDER PLUS, manufactured by Collaborativemed, LLC. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K061110 · Collaborativemed, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
48d
Days
Class 2
Risk

K061110 is an FDA 510(k) clearance for the GLUCOMMANDER PLUS. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Collaborativemed, LLC (Greenville, US). The FDA issued a Cleared decision on June 7, 2006 after a review of 48 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 - K061110

510(k) Number K061110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date June 07, 2006
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
MARC M MOUSER

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 55
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K061110.
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
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
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · Roche Diagnostics Corp. · Apr 2005
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
K011571 · The RX Files Corp. · Aug 2001
PDT DOSECALCULATOR, MODEL 80000
K000418 · Retinalabs.Com · Oct 2000

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K061110 · GLUCOMMANDER PLUS
Download PDF FDA Summary Collaborativemed, LLC