510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K942989Substantially Equivalent

Ocr II & Ocm II

Chambermaid Products Co., Cape Coral FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942989 is the FDA 510(k) clearance record for OCR II & OCM II, a class II device, cleared for Chambermaid Products Co. on under FDA product code FLE (Sterilizer, Steam). FDA records list one 510(k) clearance for Chambermaid Products Co. As of , FDA records show no recalls naming K942989.

Clearance record

Decision date
Received
(382 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Chambermaid Products Co. 3410 SE 16th Pl., Cape Coral FL
510(k) summary
Statement
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