Cleared Traditional

K233096 - PRESSUREALERT® Pressure Monitoring System (FDA 510(k) Clearance)

Class I General Hospital device.

K233096 · Position Health, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
269d
Days
Class 1
Risk

K233096 is an FDA 510(k) clearance for the PRESSUREALERT® Pressure Monitoring System. Classified as Bed-patient Activity Monitoring System (product code SBO), Class I - General Controls.

Submitted by Position Health, LLC (Lake Forest, US). The FDA issued a Cleared decision on June 21, 2024 after a review of 269 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K233096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date June 21, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SBO Bed-patient Activity Monitoring System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
Definition 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 Other Signal When Patient Activity Deviates From Assigned Pressure Prevention Parameters.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.