Cleared Traditional

K943692 - SMART DOSE(TM)

K943692 is an FDA 510(k) clearance for SMART DOSE(TM), manufactured by River Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K943692 · River Medical, Inc. · General Hospital
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Apr 1995
Decision
274d
Days
Class 2
Risk

K943692 is an FDA 510(k) clearance for the SMART DOSE(TM). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by River Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on April 28, 1995 after a review of 274 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 River Medical, Inc. devices

FDA 510(k) Submission Details - K943692

510(k) Number K943692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 28, 1994
Decision Date April 28, 1995
Days to Decision 274 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
145d slower than avg
Panel avg: 129d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 455
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K943692.
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THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
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LIFECARE 175 INFUSER, MODIFICATION
K944190 · Abbott Laboratories · May 1995
PLUM XL INFUSION PUMP
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K942161 · Pharmacia Deltec, Inc. · Aug 1994