Cleared Traditional

K810937 - ANIS IRRIGATING SPATULA

K810937 is the FDA 510(k) clearance for ANIS IRRIGATING SPATULA by American V. Mueller. It is a Class 1 Ophthalmic device (product code HND) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K810937 · American V. Mueller · Ophthalmic device
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May 1981
Decision
38d
Days
Class 1
Risk

K810937 is an FDA 510(k) clearance for the ANIS IRRIGATING SPATULA. Classified as Spatula, Ophthalmic (product code HND), Class I - General Controls.

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981 after a review of 38 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 American V. Mueller devices

Submission Details

510(k) Number K810937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date May 15, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HND Spatula, 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 - HND Spatula, Ophthalmic

Devices cleared under the same product code (HND) and FDA review panel - the closest regulatory comparables to K810937.
THORNTON TITANIUM SILVER SPATULA
K863990 · Keeler Instruments, Inc. · Oct 1986
MADDOX LENS SPATULA CAT. #7245
K801609 · Edward Weck, Inc. · Aug 1980
MCCULLEY CONTINUOUS SUTURE TIGHTNER
K801608 · Edward Weck, Inc. · Aug 1980
SPATULA'S #'S 7618,7248,7240,7242,5108
K791983 · Edward Weck, Inc. · Oct 1979
CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM
K761253 · Edward Weck, Inc. · Dec 1976