Cleared Traditional

K820889 - ASPIRATOR/IRRIGATOR OR I/A UNIT

K820889 is an FDA 510(k) clearance for ASPIRATOR/IRRIGATOR OR I/A UNIT, manufactured by Mid Laboratories, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K820889 · Mid Laboratories, Inc. · Ophthalmic device
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May 1982
Decision
36d
Days
Class 1
Risk

K820889 is an FDA 510(k) clearance for the ASPIRATOR/IRRIGATOR OR I/A UNIT. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Mid Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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.

FDA 510(k) Submission Details - K820889

510(k) Number K820889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date May 05, 1982
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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 - KYG Device, Irrigation, Ocular Surgery

All 37
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K820889.
ELECATH HEPARIN COATED THERMAL DILUTION
K832787 · Electro-Catheter Corp. · Oct 1983
MICRO SURGICAL HANDLE
K831996 · Visitec Co. · Jul 1983
LENS
K821897 · Mortan, Inc. · Jan 1983
DISPOSABLE TUBING SETS
K820680 · Innovative Surgical Products, Inc. · Apr 1982
NALGENE EMERGENCY EYE WASH
K760820 · Nagle Co. · Oct 1976
K820889 · ASPIRATOR/IRRIGATOR OR I/A UNIT
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