Cleared Traditional

K833399 - SYRINGE

K833399 is the FDA 510(k) clearance for SYRINGE by I M, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K833399 · I M, Inc. · General Hospital
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Jan 1984
Decision
97d
Days
Class 2
Risk

K833399 is an FDA 510(k) clearance for the SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 97 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 I M, Inc. devices

Submission Details

510(k) Number K833399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date January 10, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 292
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K833399.
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
MULTI PURPOSE SYRINGE
K833435 · I M, Inc. · Dec 1983
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
ANGIOUROGRAPHY KIT
K822159 · Mallinckrodt Critical Care · Nov 1982