Schiller AG: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Schiller AG” (first 1985, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 263 days. Since 2017 the median was 358 days, against 184 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 288 |
| 2017 | 1 | 177 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 447 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 451 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Schiller AG took a median 358 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 7 | 7 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 4 | 4 |
| BZG | Spirometer, Diagnostic | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (15)
- Anesthesiology (2)
Most recent Schiller AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253562 | medilogFD | MWJ | 2026-08-14 | 270 |
| K221056 | ARGUS PB-3000 | MHX | 2023-07-06 | 451 |
| K183425 | CARDIOVIT AT-102 G2 | DPS | 2020-03-02 | 447 |
| K170182 | CARDIOVIT FT-1 | DPS | 2017-07-19 | 177 |
| K152043 | Diagnostic Station DS20 | DPS | 2016-05-06 | 288 |
| K101619 | WELCH ALLYN 1500 PATIENT MONITOR | MHX | 2010-11-12 | 156 |
| K063814 | BP-200 PLUS | DXN | 2007-03-07 | 75 |
| K053207 | ARGUS, MODEL LCM | MHX | 2006-05-19 | 184 |
| K051368 | BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM | DXN | 2005-08-09 | 76 |
| K050686 | CARDIOVIT AT-10PLUS | DPS | 2005-05-04 | 49 |
7 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-08-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Schiller America, Inc. (10 510(k)s)
- Schiller Corp. (1 510(k)s)
- Schiller Medical S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Schiller AG?
FDA lists 17 510(k) clearances under the applicant name “Schiller AG” (first 1985, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Schiller AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schiller AG is 263 days. Since 2017: 358 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Schiller AG?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 7); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 4); BZG (Spirometer, Diagnostic, 2).
Next steps
- See all 17 Schiller AG clearances with predicates and recalls
- Run predicate analysis for product code DPS, Schiller AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.