Cardiovascular · 510(k) · 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
Kneevoice, Inc.. Cleared by FDA on 6 February 2026 under submission K252076, product code DQD (stethoscope, electronic). What FDA's record says, in FDA's words.
Device record · K252076
- Device. Kneevoice Cartilage Evaluation System (750-3600-001)DEVICE
- Company. Kneevoice, Inc.COMPANY
- Decision. 6 February 2026, 510(k), substantially equivalent (traditional review); received 2 July 2025DECISION
- Panel. CardiovascularPANEL
- Product code. DQD, Stethoscope, ElectronicCODE
- Regulation. 21 CFR 870.1875, Class IIREG
- Source. FDA database entry · decision document (6 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K252076Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). Kneevoice Cartilage Evaluation System (750-3600-001) [ IPlease provide your Indications for Use below. The KneeVoice Cartilage Evaluation System is intended to be used as a part of physical assessment of a patient by healthcare professional for diagnostic decision support in clinical settings. It is intended to be used by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the patellofemoral section of the knee. r Please select the types of uses (select one or both, as ZPrescription Use (Part 21 CFR 801 Subpart D) L Over-The-Counter Use (21 CFR 801 Subpart C)applicable). Kneevoice Cartilage Evaluation System 510(k) #: K252076 510(k) Summary Prepared on: 2026-02-05 Contact Details 21 CFR 807.92(a)(1) Applicant Name KneeVoice, Inc. Applicant Address 1626 Montana Avenue Santa Monica CA 90403 United States Applicant Contact Telephone 310-309-0745 Applicant Contact Gustavo DeGreiff Applicant Contact Email [email protected] Correspondent Name Marianne Grunwaldt Correspondent Address United States Correspondent Contact Telephone 305-495-7080 Correspondent Contact Marianne Grunwaldt Correspondent Contact Email [email protected] 21 CFR 807.92(a)(2) Device Trade Name Kneevoice Cartilage Evaluation System (750- 3600-001) Common […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 7 reports filed against devices carrying product code DQD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00002
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00003
8 May 2026 · Malfunction · EKO ELECTRONIC STETHOSCIPE SYSTEM · EKO HEALTH, INC. · report 3011651230-2026-00001
CUSTOMER REPORTED WHILE CHARGING THEIR DEVICE THE DEVICE BECAME VERY HOT. THE DEVICE BECAME HOT TO THE POINT THE USER COULD NOT TOUCH THE DEVICE. FOLLOWING THE EVENT THE DEVICE WAS NO LONGER ABLE TO POWER ON. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2024 · Malfunction · CORE 500 DIGITAL STETHOSCOPE · EKO HEALTH, INC. · report 3011651230-2024-00001
CUSTOMER REPORTED THAT THE REFERENCED DEVICE OVERHEATED AND THE USB-C CHARGING CABLE MELTED DURING CHARGING. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2013 · Other · 3M LITTMANN ELECTRONIC STETHOSCOPE · 3M HEALTH CARE · report 2110898-2013-00071
IT WAS REPORTED THAT A FEMALE RESPIRATORY THERAPIST, WITH A SEVERE LATEX ALLERGY, REPORTED SHE USED A SOFT BLACK EAR TIP THAT SHE BORROWED FROM HER BOSS AFTER HER SOFT GREY EAR TIP SPLIT. REPORTEDLY, SHE CLEANED IT WITH ALCOHOL BEFORE USING IT ON HER SCOPE. THE USER USED IT IN A PATIENT'S ROOM AND HER EAR BECAME BEET RED, SWOLLEN, STARTED ITCHING AND THE REACTION SPREAD TO HER HEAD, FACE, AND ARM. REPORTEDLY WENT TO THE ER AND WAS TREATED WITH BENADRYL AND DECADRON (IM INJECTION) AND A […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQD, in Cardiovascular, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.