Cleared Traditional

K232495 - Sempulse Halo Vital Signs Monitor

K232495 is an FDA 510(k) clearance for Sempulse Halo Vital Signs Monitor, manufactured by Sempulse Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K232495 · Sempulse Corporation · Anesthesiology device
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May 2024
Decision
273d
Days
Class 2
Risk

K232495 is an FDA 510(k) clearance for the Sempulse Halo Vital Signs Monitor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sempulse Corporation (San Marcos, US). The FDA issued a Cleared decision on May 16, 2024 after a review of 273 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sempulse Corporation devices

FDA 510(k) Submission Details - K232495

510(k) Number K232495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2023
Decision Date May 16, 2024
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 462
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K232495.
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