Cleared Traditional

K200916 - Patient Administration Set

K200916 is an FDA 510(k) clearance for Patient Administration Set, manufactured by Cyclomedica Australia Pty, Ltd.. The device is a Class 2 Radiology device with product code IYT cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K200916 · Cyclomedica Australia Pty, Ltd. · Radiology device
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Sep 2020
Decision
148d
Days
Class 2
Risk

K200916 is an FDA 510(k) clearance for the Patient Administration Set. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Cyclomedica Australia Pty, Ltd. (Kingsgrove, AU). The FDA issued a Cleared decision on September 1, 2020 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1390 - 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 Cyclomedica Australia Pty, Ltd. devices

FDA 510(k) Submission Details - K200916

510(k) Number K200916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date September 01, 2020
Days to Decision 148 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 107d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYT Device Classification - Class 2, Special Controls

Product Code IYT System, Rebreathing, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1390
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 Consultant

Certus International, Inc.
Karen Wolfe-Kerker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYT System, Rebreathing, Radionuclide

All 31
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K200916.
Pulmonex II Xenon System (132-503)
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XENON CIRCUIT
K953513 · King Systems Corp. · Nov 1995
XENON GAS BREATHING CIRCUIT
K952223 · Intertech Resources, Inc. · Aug 1995
BOLUS XENON CIRCUIT
K912626 · Vital Signs, Inc. · Aug 1991
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885 · Medipart Jerry Alexander · Feb 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
K896125 · Medipart Jerry Alexander · Feb 1990