Cleared Traditional

K252076 - Kneevoice Cartilage Evaluation System (750-3600-001) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252076 · Kneevoice, Inc. · Cardiovascular device
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Feb 2026
Decision
219d
Days
Class 2
Risk

K252076 is an FDA 510(k) clearance for the Kneevoice Cartilage Evaluation System (750-3600-001). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Kneevoice, Inc. (Santa Monica, US). The FDA issued a Cleared decision on February 6, 2026 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Kneevoice, Inc. devices

Submission Details

510(k) Number K252076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date February 06, 2026
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K252076.
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AccurSound Electronic Stethoscope (AS101)
K242971 · Heroic Faith International , Ltd. · Nov 2024
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K240901 · Sparrow Acoustics, Inc. · Sep 2024