ACORYS MAPPING SYSTEM— 510(k) K253861

Name: FDA 510(k) clearance K253861
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Substantially Equivalent

Corify Care S.L

FDA 510(k) clearance K253861 for ACORYS MAPPING SYSTEM, Substantially Equivalent on 2026-04-13. Applicant: Corify Care S.L. Device class: 2.

Summary

Corify Care's ACORYS MAPPING SYSTEM is filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Corify Care filed from Madrid, Spain. The decision came 131 calendar days after FDA received it (December 3, 2025 to April 13, 2026).

Clearance details

Applicant: Corify Care S.L
Product code: Product code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2025-12-03
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K261886 — VIVO (9002)2026-10-30
K254226 — PulseAPI SmartWatch2026-10-27
K263380 — STAR Apollo Mapping System2026-10-23
K263016 — Intra-Operative Positioning System (IOPS) and IOPS Visionary System2026-10-01
K254255 — S-Patch CardioAI2026-09-25

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.