Cleared Traditional

K210126 - Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% (FDA 510(k) Clearance)

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

K210126 · The Ritedose Corporation · Anesthesiology device
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Dec 2021
Decision
318d
Days
Class 2
Risk

K210126 is an FDA 510(k) clearance for the Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by The Ritedose Corporation (Columbia, US). The FDA issued a Cleared decision on December 3, 2021 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K210126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date December 03, 2021
Days to Decision 318 days
Submission Type Traditional
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
179d slower than avg
Panel avg: 139d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 506
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K210126.
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