Cleared Traditional

Nova Micro Pillows Mask Small A Model (NVP1SA) (K233829) - FDA 510(k) Clearance

Also marketed or referenced as:
Nova Micro Pillows Mask Medium A Model (NVP1MA) Nova Micro Pillows Mask Large A Model (NVP1LA) Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA) Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA) Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA) Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA) Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)

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

K233829 · Fisher and Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
266d
Days
Class 2
Risk

K233829 is an FDA 510(k) clearance for the Nova Micro Pillows Mask Small A Model (NVP1SA). Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on August 23, 2024 after a review of 266 days - an extended review cycle.

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 and Paykel Healthcare Limited devices

Submission Details

510(k) Number K233829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2023
Decision Date August 23, 2024
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 123
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