510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233096Substantially Equivalent

PRESSUREALERT® Pressure Monitoring System

Position Health, LLC, Lake Forest IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233096 is the FDA 510(k) clearance record for PRESSUREALERT® Pressure Monitoring System, a class I device, cleared for Position Health, LLC on under FDA product code SBO (Bed-Patient Activity Monitoring System). FDA's definition for product code SBO reads: "A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or...". FDA records list one 510(k) clearance for Position Health, LLC. As of , FDA records show no recalls naming K233096.

Clearance record

Decision date
Received
(269 days to decision)
Product code
SBO Bed-Patient Activity Monitoring System
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Applicant
Position Health, LLC 736 N. Western Ave., Suite 314, Lake Forest IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBO

Trailing 12 months

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

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