Cleared Traditional

K252638 - VeraPro S100 Multi-Use Syringe (018808)

Also marketed or referenced as:
VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811) VeraPro AMT Auto-Manifold and Transducer (018814) VeraPro AngioTouch FLX165 Hand Controller Kit (018806) VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)

K252638 is an FDA 510(k) clearance for VeraPro S100 Multi-Use Syringe (018808), manufactured by Acist Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K252638 · Acist Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
266d
Days
Class 2
Risk

K252638 is an FDA 510(k) clearance for the VeraPro S100 Multi-Use Syringe (018808). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 13, 2026 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Acist Medical Systems, Inc. devices

FDA 510(k) Submission Details - K252638

510(k) Number K252638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2025
Decision Date May 13, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 General Hospital devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 163
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K252638.
Disposable Syringes with Accessories for Power Injectors (900103T)
K252652 · Fortis Biosolutions Company Limited · May 2026
ACIST Pro Diagnostic System (019304)
K252653 · Acist Medical Systems, Inc. · May 2026
High Pressure Syringe
K253048 · Shenzhen Maiwei Biotech Co., Ltd. · Apr 2026
Extension tube
K251788 · Zhuhai DR Medical Instruments Co., Ltd. · Mar 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · Bayer Medical Care, Inc. · Feb 2026
High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025