Cardiovascular · 510(k) · 2023
AusculThing ACC
AusculThing Oy. Cleared by FDA on 12 July 2023 under submission K230823, product code DQD (stethoscope, electronic). What FDA's record says, in FDA's words.
Device record · K230823
- Device. AusculThing ACCDEVICE
- Company. AusculThing Oy (FI)COMPANY
- Decision. 12 July 2023, 510(k), substantially equivalent (traditional review); received 24 March 2023DECISION
- Panel. CardiovascularPANEL
- Product code. DQD, Stethoscope, ElectronicCODE
- Regulation. 21 CFR 870.1875, Class IIREG
- Source. FDA database entry · decision document (10 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.
Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [email protected] “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.” FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 5. 510(k) Summary Submitter information Name: AusculThing Ltd. Address: Ruusutorpanpuisto 4 A 15 02600 Espoo, Finland Phone: +358 50 3801 134 Contact person: Jani Virtanen, D.Sc. […]
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.
- 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 2023. 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.