Cleared Traditional

K133666 - RT016 INSPIRATORY FILTER

K133666 is an FDA 510(k) clearance for RT016 INSPIRATORY FILTER, manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K133666 · Fisher &Paykel Healthcare , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
68d
Days
Class 2
Risk

K133666 is an FDA 510(k) clearance for the RT016 INSPIRATORY FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on February 5, 2014 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fisher &Paykel Healthcare , Ltd. devices

FDA 510(k) Submission Details - K133666

510(k) Number K133666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date February 05, 2014
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · This submission: 68d
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 145
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K133666.
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132709 · Vr Medical · Jul 2014
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
K132679 · Galemed Corp. · Apr 2014
EXCELERON BACTERIAL FILTERS
K131626 · Exceleron Medical · Feb 2014
HYRDROMAX HMEF
K130664 · A-M Systems · Jun 2013
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121382 · Westmed, Inc. · Dec 2012
FLO-GUARD BREATHING FILTER
K121026 · Intersurgical, Inc. · Nov 2012