510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854861Substantially Equivalent

Setma Hygia Bath Model St 7200

Setma, Inc., Whitehouse NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854861 is the FDA 510(k) clearance record for SETMA HYGIA BATH MODEL ST 7200, a class II device, cleared for Setma, Inc. on under FDA product code ILJ (Bath, Hydro-Massage). FDA records list 3 510(k) clearances for Setma, Inc., from to . As of , FDA records show no recalls naming K854861.

Clearance record

Decision date
Received
(29 days to decision)
Product code
ILJ Bath, Hydro-Massage
Regulation
21 CFR 890.5100
Device class
Class II
Review panel
Physical Medicine
Applicant
Setma, Inc.
Third party review
No

Clearances, product code ILJ

Trailing 12 months

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

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