510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895164Substantially Equivalent

Eagle Ds

American Sterilizer Co., Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895164 is the FDA 510(k) clearance record for EAGLE DS, a class I device, cleared for American Sterilizer Co. on under FDA product code ECG (Sterilizer, Boiling Water). FDA records list 36 510(k) clearances for American Sterilizer Co., from to . As of , FDA records show no recalls naming K895164.

Clearance record

Decision date
Received
(87 days to decision)
Product code
ECG Sterilizer, Boiling Water
Regulation
21 CFR 872.6710
Device class
Class I
Review panel
Dental
Applicant
American Sterilizer Co. 2424 W. 23rd St., Erie PA
Third party review
No

Clearances, product code ECG

Trailing 12 months

FDA records hold no clearances under product code ECG in the trailing twelve months.

FDA records show no clearances under product code ECG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ECG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260