Cleared Traditional

K822928 - DISPOSABLE MICRO-INFUSION SYSTEM

K822928 is the FDA 510(k) clearance for DISPOSABLE MICRO-INFUSION SYSTEM by Orange Medical Instruments, Inc.. It is a Class 2 Microbiology device (product code FMF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K822928 · Orange Medical Instruments, Inc. · Microbiology device
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Oct 1982
Decision
22d
Days
Class 2
Risk

K822928 is an FDA 510(k) clearance for the DISPOSABLE MICRO-INFUSION SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 880.5860 - the FDA microbiology 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 Orange Medical Instruments, Inc. devices

Submission Details

510(k) Number K822928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1982
Decision Date October 26, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
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 Microbiology devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 254
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DIRECTOR
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