Cleared Traditional

K242073 - STERiJECT Ophthalmic Needle

Also marketed or referenced as:
STERiJECT Ophthalmic Needle Low Dead Space (LDS)

K242073 is an FDA 510(k) clearance for STERiJECT Ophthalmic Needle, manufactured by Tsk Laboratory International Japan KK. The device is a Class 2 General Hospital device with product code QYM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K242073 · Tsk Laboratory International Japan KK · General Hospital
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Oct 2024
Decision
99d
Days
Class 2
Risk

K242073 is an FDA 510(k) clearance for the STERiJECT Ophthalmic Needle. Classified as Ophthalmic Needle (product code QYM), Class II - Special Controls.

Submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on October 23, 2024 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Tsk Laboratory International Japan KK devices

FDA 510(k) Submission Details - K242073

510(k) Number K242073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2024
Decision Date October 23, 2024
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QYM Device Classification - Class 2, Special Controls

Product Code QYM Ophthalmic Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Ophthalmic Needle Is A Needle Intended For Intraocular Injections. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye.
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.