Cleared Traditional

MEDIJECT DISPOSABLE SYRINGES (K920039) - FDA 510(k) Clearance

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

K920039 · P.T. Igar Jaya · General Hospital
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Feb 1994
Decision
765d
Days
Class 2
Risk

K920039 is an FDA 510(k) clearance for the MEDIJECT DISPOSABLE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by P.T. Igar Jaya (Pomona, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 765 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all P.T. Igar Jaya devices

Submission Details

510(k) Number K920039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date February 09, 1994
Days to Decision 765 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
636d slower than avg
Panel avg: 129d · This submission: 765d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K920039.
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ADVANTAGE SYRINGE
K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993