510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943654Substantially Equivalent

Harvey Chemiclave Ec5000, Ec5500, Ec6000 Sterilizers

Mdt Biologic Co., Rancho Dominguez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943654 is the FDA 510(k) clearance record for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS, a class II device, cleared for Mdt Biologic Co. on under FDA product code MLR (Sterilizer, Chemical). FDA records list 8 510(k) clearances for Mdt Biologic Co., from to . As of , FDA records show no recalls naming K943654.

Clearance record

Decision date
Received
(370 days to decision)
Product code
MLR Sterilizer, Chemical
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Mdt Biologic Co. 19645 Rancho Way, Rancho Dominguez CA
510(k) summary
Statement
Third party review
No

Clearances, product code MLR

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