Simmler, Inc.: FDA clearances and approvals
Simmler, Inc. has 23 FDA 510(k) clearances (first 1980, latest 1989), across 18 product codes in 2 review panels. Median 510(k) review time: 23 days. openFDA lists 1 product recall by a recalling firm named Simmler, Inc.
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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (22)
- Hematology (1)
Most recent Simmler, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | JBB | 1989-11-29 | 64 |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | JPZ | 1988-02-11 | 72 |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | JGJ | 1988-01-21 | 73 |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | LBR | 1988-01-07 | 44 |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | CHJ | 1987-12-18 | 24 |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | CIG | 1987-11-25 | 36 |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | CIX | 1987-10-29 | 24 |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | CEO | 1987-10-28 | 23 |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | CGX | 1987-10-20 | 35 |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | CJE | 1987-10-07 | 21 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-12-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Simmler, Inc. have?
Simmler, Inc. has 23 FDA 510(k) clearances (first 1980, latest 1989), across 18 product codes in 2 review panels.
How long does FDA take to clear Simmler, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Simmler, Inc.'s cleared 510(k)s is 23 days.
What devices does Simmler, Inc. make?
Its most frequent FDA product codes are CEK (Biuret (Colorimetric), Total Protein, 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2); CIC (Cresolphthalein Complexone, Calcium, 2).
Has Simmler, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Simmler, Inc; the most recent began 2002-12-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 Simmler, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEK, Simmler, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.