Cleared Traditional

K970370 - TSK STERIJEKT PREMIUM DISPOSABLE HYPODE...

K970370 is an FDA 510(k) clearance for TSK STERIJEKT PREMIUM DISPOSABLE HYPODE..., manufactured by Tsk Laboratory, Japan. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K970370 · Tsk Laboratory, Japan · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
69d
Days
Class 2
Risk

K970370 is an FDA 510(k) clearance for the TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Tsk Laboratory, Japan (Tochigi-Shi, Tochigi-Ken, JP). The FDA issued a Cleared decision on April 10, 1997 after a review of 69 days - a notably fast clearance 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: 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 Tsk Laboratory, Japan devices

FDA 510(k) Submission Details - K970370

510(k) Number K970370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date April 10, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 275
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K970370.
2 GALLON ALTERNATE CARE SHARPS CONTAINER
K973911 · Sage Products, Inc. · Oct 1997
SHARPS SHUTTLE
K972279 · Sage Products, Inc. · Aug 1997
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · Vygon Corp. · Jun 1997
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 1997