Cleared Traditional

K130328 - F&P SIMPLUS FULL FACE MASK

K130328 is an FDA 510(k) clearance for F&P SIMPLUS FULL FACE MASK, manufactured by Fisher & Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K130328 · Fisher & Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
114d
Days
Class 2
Risk

K130328 is an FDA 510(k) clearance for the F&P SIMPLUS FULL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on June 5, 2013 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher & Paykel Healthcare Limited devices

FDA 510(k) Submission Details - K130328

510(k) Number K130328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date June 05, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 140d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 286
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K130328.
SWIFT AIR
K132013 · Resmed, Ltd. · Oct 2013
REMSTAR AUTO A-FLEX HT
K131982 · Respironics, Inc. · Oct 2013
WIZARD 230 NASAL PILOW MASK
K121642 · Apex Medical Corp. · Jun 2013
REMSTAR SE
K130077 · Respironics, Inc. · May 2013
SWIFT FX NANO
K123789 · Resmed, Ltd. · Mar 2013
KANGAROO NASAL MASK
K122847 · Respironics, Inc. · Mar 2013