Cleared Traditional

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM (K040862) - FDA 510(k) Clearance

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

K040862 · Caradyne, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
89d
Days
Class 2
Risk

K040862 is an FDA 510(k) clearance for the GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Caradyne, Ltd. (Galway, IE). The FDA issued a Cleared decision on June 30, 2004 after a review of 89 days - a notably fast clearance 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: 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 Caradyne, Ltd. devices

Submission Details

510(k) Number K040862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date June 30, 2004
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K040862.
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004
RESMED HOSPITAL FULL FACE MASK
K041362 · Resmed, Ltd. · Jul 2004
RESMED S8 PIONEER CPAP SYSTEM
K041209 · Resmed, Ltd. · Jul 2004
RESCONTROL II
K040944 · Resmed, Ltd. · Jun 2004
RESCAN
K034033 · Resmed, Ltd. · May 2004
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010 · Respironics, Inc. · May 2004