Cleared Traditional

SMARTDOSE III INFUSION CONTAINER (K944352) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944352 · River Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
435d
Days
Class 2
Risk

K944352 is an FDA 510(k) clearance for the SMARTDOSE III INFUSION CONTAINER. 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 November 15, 1995 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all River Medical, Inc. devices

Submission Details

510(k) Number K944352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 06, 1994
Decision Date November 15, 1995
Days to Decision 435 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
306d slower than avg
Panel avg: 129d · This submission: 435d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K944352.
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996
VOLUMETRIC INFUSION PUMP
K953098 · Baxter Healthcare Corp · Dec 1995
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K953731 · Abbott Laboratories · Dec 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · Abbott Laboratories · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995