Cleared Traditional

FORTUNA DISPOSABLE SYRINGES (K851519) - FDA 510(k) Clearance

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

K851519 · Impor-Tex, Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
63d
Days
Class 2
Risk

K851519 is an FDA 510(k) clearance for the FORTUNA DISPOSABLE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Impor-Tex, Intl., Inc. (Richardson, US). The FDA issued a Cleared decision on June 17, 1985 after a review of 63 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 Impor-Tex, Intl., Inc. devices

Submission Details

510(k) Number K851519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date June 17, 1985
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K851519.
MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES
K852588 · Sherwood Medical Co. · Jul 1985
MONJECT STERILE 20CC SYRINGES
K852607 · Sherwood Medical Co. · Jul 1985
MONOJECT STERILE 35CC SYRINGES
K852640 · Sherwood Medical Co. · Jul 1985
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · Sherwood Medical Co. · Apr 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985