Cleared Traditional

K121597 - ESON NASAL MASK

K121597 is an FDA 510(k) clearance for ESON NASAL 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 124-day FDA review.

K121597 · Fisher & Paykel Healthcare Limited · Anesthesiology device
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Oct 2012
Decision
124d
Days
Class 2
Risk

K121597 is an FDA 510(k) clearance for the ESON NASAL 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 October 2, 2012 after a review of 124 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 - K121597

510(k) Number K121597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date October 02, 2012
Days to Decision 124 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
16d faster than avg
Panel avg: 140d · This submission: 124d
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 K121597.
GEO
K121705 · Resmed, Ltd. · Oct 2012
REMSTAR SE
K122769 · Respironics, Inc. · Oct 2012
SIMPLE T NASAL MASK
K121631 · Respironics, Inc. · Oct 2012
MOJO, VERASEAL
K120463 · Sleepnet Corporation · Jul 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562 · Respironics, Inc. · Jul 2012
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K120035 · Apex Medical Corp. · May 2012