DeepRhythmAI

510(k) premarket notification. Decision: SESE, 11 December 2025. Product code DQK.

Clearance

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
510(k) number	K253141	k_number
Device name	DeepRhythmAI	device_name
Applicant	Medicalgorithmics S.A.	applicant
Decision date	2025-12-11	decision_date
Decision	SESE	decision
Product code	DQK	product_code
Device class	2	device_class
Review panel	null	review_panel
Clearance type	null	clearance_type
Statement or summary	null	summary_type
Regulation number	null	regulation_number
Predicate devices	null	predicate_devices

Source: FDA openFDA, device/510k, K253141, retrieved 2026-09-19 17:36 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

DQK

Computer, Diagnostic, Programmable

Device class 2 · Regulation 870.1425 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

DQK is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 13 October 2026.

ArrHub

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Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

First seen by ArrHub’s weekly snapshot: 2026-09-23 07:46 Eastern.

Raw record

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Show the raw record (JSON)device/510k.json?search=k_number:K253141&limit=1

{
  "id": "73deaa2b-e50f-4258-abed-b9700049effa",
  "k_number": "K253141",
  "device_name": "DeepRhythmAI",
  "applicant": "Medicalgorithmics S.A.",
  "decision_date": "2025-12-11",
  "decision": "SESE",
  "product_code": "DQK",
  "device_class": "2",
  "review_panel": null,
  "clearance_type": null,
  "summary_type": null,
  "regulation_number": null,
  "predicate_devices": null,
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253141",
  "verified_at": "2026-09-20T01:33:27.618+00:00",
  "created_at": "2025-12-25T21:24:41.141+00:00",
  "updated_at": "2026-09-19T21:36:08.768714+00:00",
  "collected_at": "2026-09-19T21:36:08.768714+00:00",
  "last_checked_at": null
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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