Cleared Traditional

K782169 - NEEDLES, CANNULAS, CYSTOTOMES

K782169 is an FDA 510(k) clearance for NEEDLES, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K782169 · Visitec Co. · Ophthalmic device
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Feb 1979
Decision
46d
Days
Class 1
Risk

K782169 is an FDA 510(k) clearance for the NEEDLES, CANNULAS, CYSTOTOMES. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Visitec Co. (Walker, US). The FDA issued a Cleared decision on February 13, 1979 after a review of 46 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 Visitec Co. devices

FDA 510(k) Submission Details - K782169

510(k) Number K782169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1978
Decision Date February 13, 1979
Days to Decision 46 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 110d · This submission: 46d
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 K782169.
OMS INFUSION CANNULA ASSEMBLE
K813481 · Optical Micro Systems, Inc. · Jan 1982
ANIS GUIDING CANNULA
K811455 · American V. Mueller · Jun 1981
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · Edward Weck, Inc. · Oct 1979
CANNULAS
K790243 · Visitec Co. · Feb 1979
IRRIGATION/ASPIRATION NEEDLE
K771416 · Concept, Inc. · Sep 1977