Cleared Traditional

K964833 - RMI DUAL FLUID IRRIGATING SYRINGE

K964833 is an FDA 510(k) clearance for RMI DUAL FLUID IRRIGATING SYRINGE, manufactured by Research Medical, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K964833 · Research Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
79d
Days
Class 1
Risk

K964833 is an FDA 510(k) clearance for the RMI DUAL FLUID IRRIGATING SYRINGE. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on February 19, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K964833

510(k) Number K964833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1996
Decision Date February 19, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 19
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