Cleared Traditional

K072696 - ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (FDA 510(k) Clearance)

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

K072696 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
221d
Days
Class 2
Risk

K072696 is an FDA 510(k) clearance for the ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,.... Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 2, 2008 after a review of 221 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Shenzhen Ant Hi-Tech Industrial Co., Ltd. devices

Submission Details

510(k) Number K072696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date May 02, 2008
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 125d · This submission: 221d
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 Cardiovascular 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 K072696.
Disposable Syringes with Accessories for Power Injectors (900103T)
K252652 · Fortis Biosolutions Company Limited · May 2026
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