Cleared Traditional

K252173 - F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A) (FDA 510(k) Clearance)

Also includes:
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B) F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C) F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F) F&P OptiNIV ONIV117-F Hospital Vented Full

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252173 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
61d
Days
Class 2
Risk

K252173 is an FDA 510(k) clearance for the F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circui.... Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on September 10, 2025 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: 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

Submission Details

510(k) Number K252173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2025
Decision Date September 10, 2025
Days to Decision 61 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 139d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 503
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K252173.
Inbentus Versatile
K252663 · Iconic Solutions by Murcia, SL · Apr 2026
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
AF531 Oro-Nasal SE Face Mask
K243394 · Respironics, Inc. · Dec 2024