Cleared Traditional

K223100 - Hudson RCI AquaTherm III Plus External ...

K223100 is an FDA 510(k) clearance for Hudson RCI AquaTherm III Plus External ..., manufactured by Medline Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K223100 · Medline Industries, Inc. · Anesthesiology device
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Jun 2023
Decision
270d
Days
Class 2
Risk

K223100 is an FDA 510(k) clearance for the Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on June 27, 2023 after a review of 270 days - an extended review 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: 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K223100

510(k) Number K223100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date June 27, 2023
Days to Decision 270 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
130d slower than avg
Panel avg: 140d · This submission: 270d
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 Consultant

RQM+
Joy Gutermuth

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 190
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