Cleared Traditional

K242212 - Disposable Syringe (Kit) (FDA 510(k) Clearance)

Also includes:
Nemoto Disposable Syringe (Kit)

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

K242212 · Nemoto Kyorindo Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
29d
Days
Class 2
Risk

K242212 is an FDA 510(k) clearance for the Disposable Syringe (Kit). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Nemoto Kyorindo Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on August 27, 2024 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nemoto Kyorindo Co., Ltd. devices

Submission Details

510(k) Number K242212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2024
Decision Date August 27, 2024
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K242212.
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
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2024