Cleared Traditional

K252652 - Disposable Syringes with Accessories for Power Injectors (900103T) (FDA 510(k) Clearance)

Also includes:
Disposable Syringes with Accessories for Power Injectors (900103H) Disposable Syringes with Accessories for Power Injectors (801800H) Disposable Syringes with Accessories for Power Injectors (800099T) Disposable Syringes with Accessories for Power Injectors (800099H) Disposable Syringes with Accessories for Power Injectors (800096T) Disposable Syringes with Accessories for Power Injectors (800096H) Disposable Syr

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252652 · Fortis Biosolutions Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
265d
Days
Class 2
Risk

K252652 is an FDA 510(k) clearance for the Disposable Syringes with Accessories for Power Injectors (900103T). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Fortis Biosolutions Company Limited (Taoyuan City, TW). The FDA issued a Cleared decision on May 14, 2026 after a review of 265 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 Fortis Biosolutions Company Limited devices

Submission Details

510(k) Number K252652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2025
Decision Date May 14, 2026
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 209
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K252652.
VeraPro S100 Multi-Use Syringe (018808)
K252638 · Acist Medical Systems, Inc. · 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