Wescor, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Wescor, Inc.” (first 1983, latest 2013), across 9 product codes in 6 review panels. Median 510(k) review time under this name: 52 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 | 1 | 279 |
| 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 |
|---|---|---|---|
| KTB | Device, Iontophoresis, Specific Uses | 3 | 3 |
| JJM | Osmometer For Clinical Use | 2 | 2 |
| KPA | Slide Stainer, Automated | 2 | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GJL | Romanowsky Stains | 1 | 1 |
| IAF | Wright'S Stain | 1 | 1 |
| JFS | Coulometric, Chloride | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Pathology (3)
- Physical Medicine (3)
- Hematology (1)
- General Hospital (1)
- Microbiology (1)
Most recent Wescor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | JFS | 2013-03-27 | 279 |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | KTB | 2001-03-20 | 76 |
| K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | CGZ | 1988-05-24 | 629 |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | KPA | 1988-05-13 | 31 |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | JTS | 1988-04-18 | 7 |
| K880544 | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY | GJL | 1988-04-01 | 52 |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | KTB | 1985-10-16 | 20 |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | JJM | 1984-03-30 | 116 |
| K834208 | COLLOID OSMOMETER 4400 | JJM | 1984-03-23 | 109 |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | KTB | 1984-03-19 | 45 |
3 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-01-06.
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 Wescor, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Wescor, Inc.” (first 1983, latest 2013), across 9 product codes in 6 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 Wescor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wescor, Inc. is 52 days.
Which FDA product codes appear under Wescor, Inc.?
The most frequent FDA product codes under this applicant name are KTB (Device, Iontophoresis, Specific Uses, 3); JJM (Osmometer For Clinical Use, 2); KPA (Slide Stainer, Automated, 2).
Next steps
- See all 13 Wescor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KTB, Wescor, 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.