Cleared Traditional

K231058 - Hudson RCI® AddiPak® Unit Dose Vial

K231058 is an FDA 510(k) clearance for Hudson RCI AddiPak Unit Dose Vial, manufactured by Medline Industries, LP. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K231058 · Medline Industries, LP · Anesthesiology device
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Jan 2024
Decision
266d
Days
Class 2
Risk

K231058 is an FDA 510(k) clearance for the Hudson RCI® AddiPak® Unit Dose Vial. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on January 4, 2024 after a review of 266 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, LP devices

FDA 510(k) Submission Details - K231058

510(k) Number K231058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2023
Decision Date January 04, 2024
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 339
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K231058.
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