Cleared Traditional

K051260 - SCHUCO MIST AND SCHUCO DELUXE MIST

K051260 is an FDA 510(k) clearance for SCHUCO MIST AND SCHUCO DELUXE MIST, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K051260 · Allied Healthcare Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
123d
Days
Class 2
Risk

K051260 is an FDA 510(k) clearance for the SCHUCO MIST AND SCHUCO DELUXE MIST. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on September 15, 2005 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K051260

510(k) Number K051260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2005
Decision Date September 15, 2005
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAF Nebulizer (direct Patient Interface)

All 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K051260.
MYNEB NEBULIZER, MODEL RDD100
K053203 · Respironics New Jersey, Inc. · Dec 2005
I-NEB INSIGHT AAD SYSTEM
K052941 · Profile Therapeutics Plc · Dec 2005
I-NEB AAD SYSTEM
K042991 · Profile Therapeutics Plc · Sep 2005
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
K050183 · Silvestrin Fabris S.R.L. · Aug 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · K-Jump Health Co., Ltd. · Jul 2005
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
K043238 · Emg Technology Co., Ltd. · Jul 2005