Cleared Traditional

K832605 - TRANCOJECT DISPOSABLE SYRINGES

K832605 is an FDA 510(k) clearance for TRANCOJECT DISPOSABLE SYRINGES, manufactured by Huborga, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K832605 · Huborga, Inc. · General Hospital
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Nov 1983
Decision
103d
Days
Class 2
Risk

K832605 is an FDA 510(k) clearance for the TRANCOJECT DISPOSABLE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Huborga, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Huborga, Inc. devices

FDA 510(k) Submission Details - K832605

510(k) Number K832605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1983
Decision Date November 14, 1983
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 544
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K832605.
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984
MULTI PURPOSE SYRINGE
K833435 · I M, Inc. · Dec 1983
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
ANGIOUROGRAPHY KIT
K822159 · Mallinckrodt Critical Care · Nov 1982
9110 SYRINGE
K822774 · Cardiac Pacemakers, Inc. · Nov 1982