Cleared Special

K122847 - KANGAROO NASAL MASK

K122847 is an FDA 510(k) clearance for KANGAROO NASAL MASK, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 169-day FDA review.

K122847 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
169d
Days
Class 2
Risk

K122847 is an FDA 510(k) clearance for the KANGAROO NASAL MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on March 6, 2013 after a review of 169 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K122847

510(k) Number K122847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2012
Decision Date March 06, 2013
Days to Decision 169 days
Submission Type Special
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
29d slower than avg
Panel avg: 140d · This submission: 169d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K122847.
WIZARD 230 NASAL PILOW MASK
K121642 · Apex Medical Corp. · Jun 2013
REMSTAR SE
K130077 · Respironics, Inc. · May 2013
SWIFT FX NANO
K123789 · Resmed, Ltd. · Mar 2013
QUATTRO AIR
K123979 · Resmed, Ltd. · Feb 2013
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
K112079 · Apex Medical Corp. · Dec 2012
HARD SHELL VENTED NASAL MASK
K121321 · Sleepnet Corporation · Nov 2012