Cleared Traditional

K233829 - Nova Micro Pillows Mask Small A Model (...

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)

K233829 is an FDA 510(k) clearance for Nova Micro Pillows Mask Small A Model (..., manufactured by Fisher and Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 266-day FDA review.

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

FDA 510(k) Submission Details - K233829

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.

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 285
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