Cleared Traditional

K902092 - RATEMINDER V INFUSION PUMP W/SECONDARY ...

K902092 is an FDA 510(k) clearance for RATEMINDER V INFUSION PUMP W/SECONDARY ..., manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K902092 · Critikon Company, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
78d
Days
Class 2
Risk

K902092 is an FDA 510(k) clearance for the RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 78 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K902092

510(k) Number K902092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date July 26, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 462
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K902092.
CADD-PCA AMBULATORY INFUSION PUMPS
K895644 · Pharmacia Deltec, Inc. · Aug 1990
ENTERA-FLO ENTERAL FEEDING PUMP
K894506 · Delmed, Inc. · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · Abbott Laboratories · Jul 1990