510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900574Substantially Equivalent

Abiomed Body Lead Analyzer Model 200/20

Abiomed, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900574 is the FDA 510(k) clearance record for ABIOMED BODY LEAD ANALYZER MODEL 200/20, a class II device, cleared for Abiomed, Inc. on under FDA product code JAO (Scanner, Fluorescent). FDA records list 19 510(k) clearances for Abiomed, Inc., from to . As of , FDA records show no recalls naming K900574.

Clearance record

Decision date
Received
(36 days to decision)
Product code
JAO Scanner, Fluorescent
Regulation
21 CFR 892.1220
Device class
Class II
Review panel
Radiology
Applicant
Abiomed, Inc. 33 Cherry Hill Dr., Danvers MA
Third party review
No

Clearances, product code JAO

Trailing 12 months

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

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