Cleared Traditional

K833399 - SYRINGE

K833399 is an FDA 510(k) clearance for SYRINGE, manufactured by I M, Inc.. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K833399

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.

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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K833399.
SURGICAL DISPOSABLE STERILE & NONSTERIL
K834368 · Marbex, Inc. · Mar 1984
STERILE INSULIN DISPOS. NEEDLE/SYRINGE
K840082 · Lee Medical Intl., Inc. · Feb 1984
STERILE INSULIN DISPOS. NEEDLE/GREEN
K840083 · Lee Medical Intl., Inc. · Feb 1984
SYRINGE
K834165 · Elfa Trading Co. · Dec 1983
MULTI PURPOSE SYRINGE
K833435 · I M, Inc. · Dec 1983
DISPOSABLE SYRINGES & NEEDLES
K833493 · Aldrich Chemical Co., Inc. · Nov 1983
K833399 · SYRINGE
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