510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890085Substantially Equivalent

Sit-N-Bathe Sitz Bath

Drummond Industries, Inc., Huntington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890085 is the FDA 510(k) clearance record for SIT-N-BATHE SITZ BATH, a class I device, cleared for Drummond Industries, Inc. on under FDA product code KTC (Bath, Sitz, Nonpowered). FDA records list one 510(k) clearance for Drummond Industries, Inc. As of , FDA records show no recalls naming K890085.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KTC Bath, Sitz, Nonpowered
Regulation
21 CFR 890.5125
Device class
Class I
Review panel
Physical Medicine
Applicant
Drummond Industries, Inc. 1453 Etna Ave., Huntington IN
Third party review
No

Clearances, product code KTC

Trailing 12 months

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

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