Cleared Traditional

K252076 - Kneevoice Cartilage Evaluation System (...

K252076 is an FDA 510(k) clearance for Kneevoice Cartilage Evaluation System (..., manufactured by Kneevoice, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 219-day FDA review.

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

FDA 510(k) Submission Details - K252076

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.

DQD Device Classification - Class 2, Special Controls

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 58
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