Cleared Traditional

K240305 - ANNE Limb

K240305 is an FDA 510(k) clearance for ANNE Limb, manufactured by Sibel Health, Inc.. The device is a Class 2 Cardiovascular device with product code DQA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K240305 · Sibel Health, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
116d
Days
Class 2
Risk

K240305 is an FDA 510(k) clearance for the ANNE Limb. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on May 28, 2024 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sibel Health, Inc. devices

FDA 510(k) Submission Details - K240305

510(k) Number K240305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date May 28, 2024
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05693168 Completed Interventional Industry-sponsored

Accuracy of Pulse Oximeter With Profound Hypoxia

12
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Hypoxia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Sibel Health Inc. (industry)
Started 2021-06-23 → Primary completion 2021-06-24
Primary outcome
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K240305.
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