Cleared Traditional

K221436 - F&P 950 Accessory Breathing Circuit Kits

K221436 is the FDA 510(k) clearance for F&P 950 Accessory Breathing Circuit Kits by Fisher &Paykel Healthcare , Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K221436 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
408d
Days
Class 2
Risk

K221436 is an FDA 510(k) clearance for the F&P 950 Accessory Breathing Circuit Kits. 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 June 29, 2023 after a review of 408 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K221436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2022
Decision Date June 29, 2023
Days to Decision 408 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
268d slower than avg
Panel avg: 140d · This submission: 408d
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 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K221436.
Oran Park Mask
K230476 · Resmed Pty Ltd (Registration Number: 3004604967) · Oct 2023
Therapy Mask 3100 NC/SP
K231313 · Respironics, Inc. · Jul 2023
Whitsundays Mask System
K223747 · Resmed Pty Ltd (Registration Number: 3004604967) · Jul 2023
F&P Solo Mask Range
K223696 · Fisher &Paykel Healthcare , Ltd. · May 2023
Luna G3 BPAP System
K212263 · 3B Medical, Inc. · Mar 2022
F&P Evora Full Face Mask
K212371 · Fisher &Paykel Healthcare , Ltd. · Mar 2022