Cleared Traditional

K813314 - NLD IMPLANT SET

K813314 is the FDA 510(k) clearance for NLD IMPLANT SET by Design Research Assoc., Inc.. It is a Class 1 Ophthalmic device (product code HMX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K813314 · Design Research Assoc., Inc. · Ophthalmic device
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Feb 1982
Decision
92d
Days
Class 1
Risk

K813314 is an FDA 510(k) clearance for the NLD IMPLANT SET. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Design Research Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Design Research Assoc., Inc. devices

Submission Details

510(k) Number K813314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date February 24, 1982
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 39
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K813314.
OPHTHALMIC CANNULA
K872151 · Pharmacia, Inc. · Jun 1987
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · Storz Instrument Co. · Feb 1986
SITE ANTERIOR CAPSULOTOMER
K843039 · Chiron Vision Corp. · Nov 1984
ANIS GUIDING CANNULA
K811455 · American V. Mueller · Jun 1981
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · Edward Weck, Inc. · Oct 1979
NEEDLES, CANNULAS, CYSTOTOMES
K782169 · Visitec Co. · Feb 1979