Cleared Traditional

INMAN IRRIGATION TAPERED PROBE (K933171) - FDA 510(k) Clearance

Class I General Hospital device.

K933171 · Inman Medical Corp. · General Hospital
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Apr 1994
Decision
304d
Days
Class 1
Risk

K933171 is an FDA 510(k) clearance for the INMAN IRRIGATION TAPERED PROBE. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Inman Medical Corp. devices

Submission Details

510(k) Number K933171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date April 29, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 129d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.