Cleared Special

K023805 - LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

K023805 is an FDA 510(k) clearance for LAERDAL PAEDIATRIC POCKET MASK, manufactured by Laerdal Medical A/S. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Special 510(k) pathway after a 89-day FDA review.

K023805 · Laerdal Medical A/S · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
89d
Days
Class 2
Risk

K023805 is an FDA 510(k) clearance for the LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on February 11, 2003 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023805

510(k) Number K023805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date February 11, 2003
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 85
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K023805.
BAWMED RESCUE MASK
K031431 · Bawmed UK · Jul 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366 · Fisher &Paykel Healthcare , Ltd. · Mar 2004
MODIFICATION TO HIOX
K030943 · Sensor Medics Corp. · Apr 2003
HI-OX
K020665 · Sensor Medics Corp. · Jul 2002
Y2000 POCKET RESCUE
K010191 · Cheen Houng Ent. Co. , Ltd. · Mar 2001
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · Laerdal Medical Corp. · Oct 2000