Cleared Traditional

K900187 - ADVANCE CONTRAST MEDIA SETS (VARYING LE...

K900187 is an FDA 510(k) clearance for ADVANCE CONTRAST MEDIA SETS (VARYING LE..., manufactured by Advance Medical Designs, Inc.. The device is a Class 2 Radiology device with product code FPA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K900187 · Advance Medical Designs, Inc. · Radiology device
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May 1990
Decision
105d
Days
Class 2
Risk

K900187 is an FDA 510(k) clearance for the ADVANCE CONTRAST MEDIA 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

FDA 510(k) Submission Details - K900187

510(k) Number K900187 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
Combination Product No
PCCP Authorized No
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.

FPA Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K900187.
STERILE I.V. START KIT
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K902166 · Therex Corp. · Aug 1990
IN-LINE VIAL CONNECTION SITE
K900909 · Baxter Healthcare Corp · May 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188 · Advance Medical Designs, Inc. · May 1990
EXTENSION SET
K896561 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
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K896346 · Pharmacia Deltec, Inc. · Jan 1990