ARGUS PB-3000— 510(k) K221056

Name: FDA 510(k) clearance K221056
Creator: U.S. Food and Drug Administration
Published: 2023-07-06

Substantially Equivalent

Schiller AG

FDA 510(k) clearance K221056 for ARGUS PB-3000, Substantially Equivalent on 2023-07-06. Applicant: Schiller AG. Device class: 2.

Clearance details

Applicant: Schiller AG
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2022-04-11
Decision date: 2023-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

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K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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 →

Recalls naming K221056

K-number listed on FDA's recall record

Z-2672-2025 — Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006Class II·Ongoing·Schiller, Ag·20250808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221056.

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