510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103536Substantially Equivalent

Ibed Wireless with Ibed Awareness

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103536 is the FDA 510(k) clearance record for IBED WIRELESS WITH IBED AWARENESS, a class II device, cleared for Stryker Corporation on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show no recalls naming K103536.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Applicant
Stryker Corporation 3800 E. Centre Ave., Portage MI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FNL

Trailing 12 months

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

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