Cleared Traditional

K063526 - A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER

K063526 is an FDA 510(k) clearance for A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL..., manufactured by A-M Systems, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K063526 · A-M Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
219d
Days
Class 2
Risk

K063526 is an FDA 510(k) clearance for the A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by A-M Systems, Inc. (Roswell, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 219 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K063526

510(k) Number K063526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date June 29, 2007
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - CAH Filter, Bacterial, Breathing-circuit

All 196
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K063526.
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
K091185 · Hsiner Co., Ltd. · Jul 2009
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · Medisize BV · Jan 2009
FILTER CARESTAR 30
K072002 · Draeger Medical AG & Co. KG · Jan 2008
FILTERFLO HEPA
K063125 · Arc Medical, Inc. · Apr 2007
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K061426 · Porous Media Corp. · Jun 2006
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
K052087 · Ag Industries · Dec 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K063526 · A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
Download PDF FDA Summary A-M Systems, Inc.