510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000420Substantially Equivalent

Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003

Retinalabs.Com, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000420 is the FDA 510(k) clearance record for SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003, a class II device, cleared for Retinalabs.Com on under FDA product code MRH (Pump, Infusion, Ophthalmic). FDA records list 5 510(k) clearances for Retinalabs.Com, from to . As of , FDA records show no recalls naming K000420.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MRH Pump, Infusion, Ophthalmic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Retinalabs.Com 1776 Peachtree St., Atlanta GA
510(k) summary
Summary
Third party review
No

Clearances, product code MRH

Trailing 12 months
1 clearance under product code MRH in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260