Simmler & Son, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Simmler & Son, Inc.” (first 1976, latest 1978), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 | 4 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (13)
Most recent Simmler & Son, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780817 | GLOBIN-TERGE | — | 1978-07-27 | 70 |
| K771906 | PHOSPHATE | CDT | 1977-12-06 | 60 |
| K771905 | GLYCEROL SUBSTRATE | CDT | 1977-12-06 | 60 |
| K771904 | GLYCEROL KINASE | CDT | 1977-12-06 | 60 |
| K771903 | LIPASE | CDT | 1977-12-06 | 60 |
| K761086 | REAGENTS | JJC | 1977-01-12 | 58 |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | CFJ | 1976-11-01 | 76 |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | CEK | 1976-10-29 | 73 |
| K760479 | REAGENT, TOTAL BILIRUBIN DETERMINATION | CIG | 1976-10-29 | 73 |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | CDW | 1976-10-29 | 73 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Simmler & Son, 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.
- Simmler, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Simmler & Son, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Simmler & Son, Inc.” (first 1976, latest 1978), across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Simmler & Son, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Simmler & Son, Inc. is 73 days.
Which FDA product codes appear under Simmler & Son, Inc.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 4); CDH (Acid, Uric, Phosphotungstate Reduction, 1); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1).
Next steps
- See all 14 Simmler & Son, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Simmler & Son, 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.