Cleared Traditional

K915074 - IRRIGATOR/ASPIRATOR PROBE

K915074 is an FDA 510(k) clearance for IRRIGATOR/ASPIRATOR PROBE, manufactured by Biomedical Dynamics, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K915074 · Biomedical Dynamics, Inc. · Ophthalmic device
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Feb 1992
Decision
89d
Days
Class 1
Risk

K915074 is an FDA 510(k) clearance for the IRRIGATOR/ASPIRATOR PROBE. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Biomedical Dynamics, Inc. (Burnsville, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 Biomedical Dynamics, Inc. devices

FDA 510(k) Submission Details - K915074

510(k) Number K915074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date February 05, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HMX Cannula, Ophthalmic

All 49
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K915074.
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · American Medical Devices, Inc. · May 1997
KIRWAN IRRIGATION/ASPIRATION HANDPIECE
K930113 · Kirwan Surgical Products, Inc. · Feb 1994
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
K921488 · Surgical Technologies, Inc. · May 1992
VITREORETINAL INFUSION CANNULA
K904074 · Visitec Co. · Feb 1991
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988