Cleared Traditional

K233904 - ACIST RXi System (016616)

Also marketed or referenced as:
ACIST Navvus II Catheter (016675_

K233904 is an FDA 510(k) clearance for ACIST RXi System (016616), manufactured by Acist Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K233904 · Acist Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
219d
Days
Class 2
Risk

K233904 is an FDA 510(k) clearance for the ACIST RXi System (016616). Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 17, 2024 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Acist Medical Systems, Inc. devices

FDA 510(k) Submission Details - K233904

510(k) Number K233904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2023
Decision Date July 17, 2024
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 33
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K233904.
OptoMonitor 3
K251367 · Opsens, Inc. · Jan 2026
OptoMonitor 3
K241418 · Opsens, Inc. · Feb 2025
TruWave Disposable Pressure Transducer
K222216 · Edwards Lifesciences, LLC · Dec 2022
OptoMonitor 3
K202943 · Opsens, Inc. · Nov 2020
OptoMonitor 3
K193620 · Opsens, Inc. · Jun 2020
Comet II Pressure Guidewire
K193279 · Boston Scientific Corporation · Dec 2019