510(k) Report

FDA applicant

Schiller AG

Baar, CH18 decisions1985–20262 recalls

FDA records 18 decisions for Schiller AG (Baar, CH) from 1985 to 2026: 18 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 288 days from receipt to decision, against 229 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 12 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Schiller Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Schiller AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12010: 12016: 12017: 12020: 12023: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 12025: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Schiller AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Schiller AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DPSElectrocardiograph8decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)4decisions
  • BZGSpirometer, Diagnostic2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DSKComputer, Blood-Pressure1decision
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 288 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 229 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012226Monitoring System,Model Argus PB-1000Schiller AG · 20024cite it
  • K050686Cardiovit at-10PLUSSchiller AG · 20052cite it
  • K031557Cardiovit at-102Schiller AG · 20042cite it
  • K063814BP-200 PlusSchiller AG · 20072cite it
  • K992823Spirovit SP-2, Pneumocheck IISchiller AG · 20001cites it
  • K984031Spirovit, Model SP-250Schiller AG · 19991cites it

What has FDA decided for it lately?

  • K253562medilogFDSchiller AG · 2026
  • K221056Argus PB-3000Schiller AG · 20231 recall
  • K183425Cardiovit at-102 G2Schiller AG · 20201 recall
  • K170182Cardiovit FT-1Schiller AG · 2017
  • K152043Diagnostic Station DS20Schiller AG · 2016
  • K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010
  • K063814BP-200 PlusSchiller AG · 2007
  • K053207Argus, Model LCMSchiller AG · 2006

All 17 as Schiller AG →The one decision as Schiller Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K221056Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006Aug 8, 2025Class II
  • K183425CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570Jul 24, 2024Class II

Other applicant names beginning “Schiller”

FDA records each applicant name separately; these may or may not be the same firm.

Schiller America, Inc. 10Schiller Medical S.A. 1