510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822557Substantially Equivalent

Specimen Adaptor

Bemis Health Care, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822557 is the FDA 510(k) clearance record for SPECIMEN ADAPTOR, a class II device, cleared for Bemis Health Care on under FDA product code BYZ (Trap, Sterile Specimen). FDA records list 12 510(k) clearances for Bemis Health Care, from to . As of , FDA records show no recalls naming K822557.

Clearance record

Decision date
Received
(55 days to decision)
Product code
BYZ Trap, Sterile Specimen
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Bemis Health Care 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYZ

Trailing 12 months

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

FDA records show no clearances under product code BYZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYZ, 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