Cleared Traditional

K231058 - Hudson RCI AddiPak Unit Dose Vial

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

K231058 · Medline Industries, LP · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 134
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K231058.
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
K233553 · Thayer Medical Corporation · Jun 2024
Aerogen®Solo Nebulizer System
K232507 · Aerogen, Ltd. · May 2024
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
K232523 · Mankind Pharma Limited · Apr 2024
Portable (Ultrasonic) Nebulizer
K230379 · Dongguan Simzo Electronic Technology Co., Ltd. · Nov 2023
Hudson RCI® TurboMist™ Nebulizer System
K230602 · Medline Industries, LP · Oct 2023
Ochsner Connected Inhaler Sensor
K223367 · Ochsner Clinic Foundation · Aug 2023