Cleared Traditional

K053203 - MYNEB NEBULIZER, MODEL RDD100

K053203 is an FDA 510(k) clearance for MYNEB NEBULIZER, manufactured by Respironics New Jersey, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K053203 · Respironics New Jersey, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
34d
Days
Class 2
Risk

K053203 is an FDA 510(k) clearance for the MYNEB NEBULIZER, MODEL RDD100. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respironics New Jersey, Inc. (Cedar Grove, US). The FDA issued a Cleared decision on December 20, 2005 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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.

FDA 510(k) Submission Details - K053203

510(k) Number K053203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date December 20, 2005
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 440
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K053203.
AEROECLIPSE II BREATH ACTUATED NEBULIZER
K053605 · Trudell Medical Intl. · Feb 2006
EMG HANDLE NEBULIZER NB02 SERIES
K052438 · Emg Technology Co., Ltd. · Jan 2006
HSINER JET NEBULIZER, MODEL HS-31100
K052811 · Hsiner Co., Ltd. · Dec 2005
I-NEB INSIGHT AAD SYSTEM
K052941 · Profile Therapeutics Plc · Dec 2005
I-NEB AAD SYSTEM
K042991 · Profile Therapeutics Plc · Sep 2005
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · Allied Healthcare Products, Inc. · Sep 2005