Cleared Traditional

K933171 - INMAN IRRIGATION TAPERED PROBE

K933171 is an FDA 510(k) clearance for INMAN IRRIGATION TAPERED PROBE, manufactured by Inman Medical Corp.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 304-day FDA review.

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

FDA 510(k) Submission Details - K933171

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.

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 15
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K933171.
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SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K940371 · Micromedics, Inc. · Apr 1994
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993