Cleared Traditional

RATEMINDER III INFUSION DEVICE (K855000) - FDA 510(k) Clearance

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

K855000 · American Edwards Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
61d
Days
Class 2
Risk

K855000 is an FDA 510(k) clearance for the RATEMINDER III INFUSION DEVICE. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Edwards Laboratories devices

Submission Details

510(k) Number K855000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1985
Decision Date February 12, 1986
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDR Controller, Infusion, Intravascular, Electronic
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 - LDR Controller, Infusion, Intravascular, Electronic

All 59
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K855000.
DEKA Infusion System, DEKA Administration Set
K242693 · Deka Research and Development Corporation · Oct 2024
DEKA Infusion System, DEKA Administration Set
K232316 · Deka Research and Development · Mar 2024
3M IV FLOW REGULATOR
K896907 · 3M Company · Feb 1990
LIFECARE 75 CONTROLLER
K893487 · Abbott Laboratories · Jul 1989
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984
LIFECARE 1000 CONTROLLER
K812114 · Abbott Laboratories · Aug 1981