Trace America, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Trace America, Inc.” (first 1988, latest 2001), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Trace America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | NDW | 2001-01-17 | 58 |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CFR | 1998-03-10 | 64 |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CKA | 1998-02-02 | 28 |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CIT | 1998-01-30 | 25 |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | CKA | 1998-01-07 | 105 |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | JIF | 1998-01-02 | 22 |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | JFJ | 1997-07-17 | 28 |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CDO | 1997-05-27 | 34 |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | CDQ | 1997-05-27 | 34 |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | LBR | 1997-03-13 | 241 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trace 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.
- Trace Scientific , Ltd. (55 510(k)s)
- Trace Medical Equipment, Inc. (2 510(k)s)
- Trace Analytical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trace America, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Trace America, Inc.” (first 1988, latest 2001), across 16 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 Trace America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trace America, Inc. is 55 days.
Which FDA product codes appear under Trace America, Inc.?
The most frequent FDA product codes under this applicant name are KHS (Enzymatic, Carbon-Dioxide, 3); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 2).
Next steps
- See all 22 Trace America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KHS, Trace 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.