Cleared Traditional

STERICOVER (K853044) - FDA 510(k) Clearance

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

K853044 · Sterimed, Inc. · Radiology device
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Nov 1985
Decision
105d
Days
Class 2
Risk

K853044 is an FDA 510(k) clearance for the STERICOVER. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Sterimed, Inc. (Acworth, US). The FDA issued a Cleared decision on November 1, 1985 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 892.1600 - 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 Sterimed, Inc. devices

Submission Details

510(k) Number K853044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date November 01, 1985
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 IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 49
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K853044.
LC, CARDIAC POSITIONER #B5078A
K890348 · General Electric Co. · Feb 1989
MULTISKOP
K890352 · Siemens Medical Solutions USA, Inc. · Feb 1989
ANGIOSTAR
K884912 · Siemens Medical Solutions USA, Inc. · Feb 1989
OMEGA II ANGIOGRAPHIC TABLE
K812913 · General Electric Co. · Nov 1981
PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION
K810183 · Philips Medical Systems (Cleveland), Inc. · Feb 1981