Cleared Traditional

K013027 - MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 (FDA 510(k) Clearance)

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

K013027 · Respironics Healthscan, Inc. · Anesthesiology device
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Dec 2001
Decision
87d
Days
Class 2
Risk

K013027 is an FDA 510(k) clearance for the MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Respironics Healthscan, Inc. (Great Neck, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 Respironics Healthscan, Inc. devices

Submission Details

510(k) Number K013027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2001
Decision Date December 06, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 139d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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.