510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911843Substantially Equivalent

Zero-G(tm) Gel/foam Mattress Topper

Steridyne Corp., Riviera Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911843 is the FDA 510(k) clearance record for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER, a class I device, cleared for Steridyne Corp. on under FDA product code KIC (Cushion, Flotation). FDA records list 6 510(k) clearances for Steridyne Corp., from to . As of , FDA records show no recalls naming K911843.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KIC Cushion, Flotation
Regulation
21 CFR 890.3175
Device class
Class I
Review panel
Physical Medicine
Applicant
Steridyne Corp. 3725 Investment Ln., Riviera Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code KIC

Trailing 12 months

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

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