510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012573Substantially Equivalent

Castle 400Hc/500hc Series Steam Sterilizer, Models 422Hc, 433Hc, 522Hc, and 533Hc

Getinge/Castle, Inc., Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012573 is the FDA 510(k) clearance record for CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC, a class II device, cleared for Getinge/Castle, Inc. on under FDA product code FLE (Sterilizer, Steam). FDA records list 9 510(k) clearances for Getinge/Castle, Inc., from to . As of , FDA records show no recalls naming K012573.

Clearance record

Decision date
Received
(27 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Getinge/Castle, Inc. 1777 E. Henrietta Rd., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260