Cleared Traditional

K833435 - MULTI PURPOSE SYRINGE

K833435 is the FDA 510(k) clearance for MULTI PURPOSE 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 68-day FDA review.

K833435 · I M, Inc. · General Hospital
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Dec 1983
Decision
68d
Days
Class 2
Risk

K833435 is an FDA 510(k) clearance for the MULTI PURPOSE 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 December 12, 1983 after a review of 68 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 I M, Inc. devices

Submission Details

510(k) Number K833435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date December 12, 1983
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K833435.
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
ANGIOUROGRAPHY KIT
K822159 · Mallinckrodt Critical Care · Nov 1982
9110 SYRINGE
K822774 · Cardiac Pacemakers, Inc. · Nov 1982