Cleared Traditional

K900188 - ADVANCE ADMINISTRATION SETS (VARYING LENGTH) (FDA 510(k) Clearance)

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

K900188 · Advance Medical Designs, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
105d
Days
Class 2
Risk

K900188 is an FDA 510(k) clearance for the ADVANCE ADMINISTRATION SETS (VARYING LENGTH). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on May 1, 1990 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5440 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K900188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date May 01, 1990
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 Radiology devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K900188.
PuraCath Firefly Needleless Connector IT (9005)
K251375 · Puracath Medical, Inc. · Feb 2026
nSet+ Stabilization Set [6426733]
K251257 · Np Medical · Dec 2025
BD Alaris Pump Infusion Set
K250325 · Carefusion (Bd) · Oct 2025
EZ™ IV Administration Set
K251814 · Epic Medical Pte. , Ltd. · Aug 2025
SteadiSet infusion set
K251854 · Tandem Diabetes Care · Aug 2025
Sparta Infusion Set for Insulin
K243841 · Deka Research and Development · Aug 2025