Cleared Traditional

K231734 - STERiJECT Low Dead Space, STERiJECT The Invisible Needle (FDA 510(k) Clearance)

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

K231734 · Tsk Laboratory International Japan KK · General Hospital
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Mar 2024
Decision
268d
Days
Class 2
Risk

K231734 is an FDA 510(k) clearance for the STERiJECT Low Dead Space, STERiJECT The Invisible Needle. Classified as Low Dead Space Needle, Single Lumen, Hypodermic (product code QNS), Class II - Special Controls.

Submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on March 8, 2024 after a review of 268 days - an extended review cycle.

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

Submission Details

510(k) Number K231734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2023
Decision Date March 08, 2024
Days to Decision 268 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
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNS Low Dead Space Needle, Single Lumen, Hypodermic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.
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.