510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914921Substantially Equivalent

Scm-3 and Accessories

Gaymar Industries, Inc., Orchard Park NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914921 is the FDA 510(k) clearance record for SCM-3 AND ACCESSORIES, a class I device, cleared for Gaymar Industries, Inc. on under FDA product code IKY (Mattress, Flotation Therapy, Non-Powered). FDA records list 27 510(k) clearances for Gaymar Industries, Inc., from to . As of , FDA records show no recalls naming K914921.

Clearance record

Decision date
Received
(129 days to decision)
Product code
IKY Mattress, Flotation Therapy, Non-Powered
Regulation
21 CFR 880.5150
Device class
Class I
Review panel
General Hospital
Applicant
Gaymar Industries, Inc. 10 Centre Dr., Orchard Park NY
510(k) summary
Statement
Third party review
No

Clearances, product code IKY

Trailing 12 months

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

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