Esa, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Esa, Inc.” (first 1987, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| CHQ | Chromatographic/Fluorometric Method, Catecholamines | 3 | 3 |
| LEQ | Detectors, Electrochemical, Liquid Chromatography | 2 | 2 |
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | 1 |
| DOF | Lead, Atomic Absorption | 1 | 1 |
Review panels
Most recent Esa, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032199 | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | CHQ | 2004-01-30 | 196 |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | DOF | 1997-09-09 | 130 |
| K963938 | MODEL 5500 CEAS | CHQ | 1996-12-26 | 86 |
| K934977 | MODEL 5500 CEAS | CDF | 1994-01-11 | 84 |
| K931148 | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | CHQ | 1993-06-09 | 96 |
| K903231 | COULOCHEM II | LEQ | 1990-09-27 | 66 |
| K864729 | NEUROCHEMICAL ANALYZER | LEQ | 1987-04-13 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Esa, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Esa, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Esa, Inc.” (first 1987, latest 2004), across 4 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 Esa, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Esa, Inc. is 96 days.
Which FDA product codes appear under Esa, Inc.?
The most frequent FDA product codes under this applicant name are CHQ (Chromatographic/Fluorometric Method, Catecholamines, 3); LEQ (Detectors, Electrochemical, Liquid Chromatography, 2); CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, 1).
Next steps
- See all 7 Esa, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHQ, Esa, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.