Cleared Traditional

K973510 - DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

K973510 is an FDA 510(k) clearance for DUPLOJECT (0.5/1.0 ML, manufactured by Immuno-U.S., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K973510 · Immuno-U.S., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
83d
Days
Class 2
Risk

K973510 is an FDA 510(k) clearance for the DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Immuno-U.S., Inc. (Rockville, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 83 days - a notably fast clearance cycle.

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: 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 Immuno-U.S., Inc. devices

FDA 510(k) Submission Details - K973510

510(k) Number K973510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1997
Decision Date December 08, 1997
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 389
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K973510.
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
K972877 · Safety Syringes, Inc. · Feb 1998
ULTRASAFE MODEL T200 INJECTOR
K972900 · Safety Syringes, Inc. · Feb 1998
DAXOR MAX100 SYRINGE (MAX100)
K970419 · Daxor Corporation · Dec 1997
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
K972878 · Safety Syringes, Inc. · Oct 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · Biosurgical Corp. · Sep 1997
RAMY PISTON SYRINGE
K971664 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997