Cleared Traditional

K191596 - Arcadia Balloon Catheter

K191596 is an FDA 510(k) clearance for Arcadia Balloon Catheter, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K191596 · Merit Medical Systems, Inc. · Orthopedic device
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Oct 2019
Decision
114d
Days
Class 2
Risk

K191596 is an FDA 510(k) clearance for the Arcadia Balloon Catheter. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 9, 2019 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K191596

510(k) Number K191596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2019
Decision Date October 09, 2019
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 526
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K191596.
Osteo-site Vertebral Balloon
K200763 · Izi Medical · Aug 2020
Smith+Nephew Arthroscopes
K201349 · Smith & Nephew · Jul 2020
HydroCision SpineJet System
K200729 · Hydrocision, Inc. · Apr 2020
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · Smith & Nephew, Inc. · Sep 2019
Pegasus System
K191345 · A.M. Surgical, Inc. · Jul 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · Stryker Corp. · Jul 2019