Cleared Traditional

K130664 - HYRDROMAX HMEF

K130664 is an FDA 510(k) clearance for HYRDROMAX HMEF, manufactured by A-M Systems. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K130664 · A-M Systems · General Hospital
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Jun 2013
Decision
101d
Days
Class 2
Risk

K130664 is an FDA 510(k) clearance for the HYRDROMAX HMEF. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by A-M Systems (Bonita Springs, US). The FDA issued a Cleared decision on June 21, 2013 after a review of 101 days - within the typical 510(k) review window.

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.

View all A-M Systems devices

FDA 510(k) Submission Details - K130664

510(k) Number K130664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date June 21, 2013
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAH Filter, Bacterial, Breathing-circuit

All 105
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K130664.
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
FLO-GUARD BREATHING FILTER
K121026 · Intersurgical, Inc. · Nov 2012
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010