Cleared Traditional

F&P SleepStyle (K173193) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K173193 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Aug 2018
Decision
310d
Days
Class 2
Risk

K173193 is an FDA 510(k) clearance for the F&P SleepStyle. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 8, 2018 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 , Ltd. devices

Submission Details

510(k) Number K173193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date August 08, 2018
Days to Decision 310 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
171d slower than avg
Panel avg: 139d · This submission: 310d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02948010 Completed Interventional Industry-sponsored

CPAP Device In-lab Assessment NZ

104
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Obstructive Sleep Apnea
Study design Crossover
Eligibility All sexes · 18 Years+
Sponsor Fisher and Paykel Healthcare (industry)
Started 2016-11-01 → Primary completion 2017-03-01
Primary outcome
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Secondary outcome
Participant perception of the device, as determined by the questionnaire responses
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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

All 118
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K173193.
Moore Park Mask
K183512 · Resmed, Ltd. · May 2019
Care Orchestrator
K181053 · Respironics, Inc. · Jan 2019
Transcend 365 miniCPAP System
K180388 · Somnetics International, Inc. · Nov 2018
Scone Mask
K180497 · Resmed, Ltd. · Jun 2018
Bleep DreamPort
K172335 · Snapcpap · Mar 2018
AirFit F20
K170924 · Resmed, Ltd. · Jan 2018