Schiller America, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Schiller America, Inc.” (first 1990, latest 1998), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 130 days. 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 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOS | 4 | 4 | |
| BZG | Spirometer, Diagnostic | 2 | 2 |
| DPS | Electrocardiograph | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (2)
Most recent Schiller America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973751 | MT-200 | DQK | 1998-08-25 | 328 |
| K973735 | MICROVIT MT-100 | DSH | 1998-08-25 | 329 |
| K970879 | CARDIOVIT CS-200 | LOS | 1997-06-25 | 107 |
| K953396 | CARDIOVIT AT-1C, AT-2C | LOS | 1995-12-19 | 152 |
| K954066 | MINISCOPE MS-3 | DPS | 1995-10-27 | 58 |
| K941462 | CARDIOVIT AT-5C | LOS | 1995-05-19 | 421 |
| K946205 | CARDIOVIT AT-1, P-80 | DPS | 1995-03-16 | 85 |
| K914970 | CARDIOVIT CS-100 | LOS | 1992-11-03 | 364 |
| K896121 | SCHILLER MODEL SP-200 SPIROVIT(TM) | BZG | 1990-01-09 | 77 |
| K896120 | SCHILLER MODEL SP-100 SPIROVIT(TM) | BZG | 1990-01-09 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Schiller America, Inc..
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 AG (17 510(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 America, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Schiller America, Inc.” (first 1990, latest 1998), across 5 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 America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schiller America, Inc. is 130 days.
Which FDA product codes appear under Schiller America, Inc.?
The most frequent FDA product codes under this applicant name are LOS (device, 4); BZG (Spirometer, Diagnostic, 2); DPS (Electrocardiograph, 2).
Next steps
- See all 10 Schiller America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOS, Schiller America, Inc.'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.