Cleared Traditional

TRUJECT (K945284) - FDA 510(k) Clearance

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

K945284 · Clive Craig Co. · General Hospital
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Dec 1994
Decision
59d
Days
Class 2
Risk

K945284 is an FDA 510(k) clearance for the TRUJECT. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Clive Craig Co. (Oxnard, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 59 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 Clive Craig Co. devices

Submission Details

510(k) Number K945284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date December 29, 1994
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K945284.
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · Baxter Healthcare Corp · Nov 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1994
MONOJECT LUER ADAPTER
K940961 · Sherwood Medical Co. · Sep 1994