510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922816Substantially Equivalent

U P Custom Design, Inc. Cot Equipment Carrier

Up Custom Design, Inc., Menominee MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922816 is the FDA 510(k) clearance record for U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER, a class I device, cleared for Up Custom Design, Inc. on under FDA product code FPP (Stretcher, Hand-Carried). FDA records list one 510(k) clearance for Up Custom Design, Inc. As of , FDA records show no recalls naming K922816.

Clearance record

Decision date
Received
(397 days to decision)
Product code
FPP Stretcher, Hand-Carried
Regulation
21 CFR 880.6900
Device class
Class I
Review panel
General Hospital
Applicant
Up Custom Design, Inc. P.O. Box 734, Menominee MI
510(k) summary
Summary
Third party review
No

Clearances, product code FPP

Trailing 12 months

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

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