Kneevoice Cartilage Evaluation System (750-3600-001)

K252076

Kneevoice, Inc. · cleared 2026-02-06 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Kneevoice™™ Cartilage Auscultation System (CAS) is a system that captures the sounds and vibrations emitted by the articular cartilage during joint motion. The Kneevoice CAS device consists of an audio and position sensor assembly cabled to a digital console. The console consists of an enclosure, power components, a touch screen display, a processor and memory. The console is mounted to a desktop stand. In use, the audio and position sensor assembly is attached to the top of the patient's patella using the disposable self-adhesive patches. The audio sensor listens to the sounds produced by the patellofemoral joint while the patient flexes their knee eight times from a 0 to 90 degree range of motion. The audio and position sensor electronics send the sound and motion data to the console over a cable. The console receives the data stream and performs noise reduction, band-pass filtering and pattern recognition.”
Algorithmnoise reduction, band-pass filtering and pattern recognition
source quote (p.5)
“The console receives the data stream and performs noise reduction, band-pass filtering and pattern recognition.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252076