Western Laboratories Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Western Laboratories Corp.” (first 1978, latest 1984), across 7 product codes in 3 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 |
|---|---|---|---|
| FIZ | Meter, Conductivity, Non-Remote | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| FLB | Meter, Conductivity, Induction, Remote Type | 1 | 1 |
| FTZ | Locator, Magnetic | 1 | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (4)
- Hematology (1)
- Ophthalmic (1)
Most recent Western Laboratories Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834024 | HEPARINOMETER | KFF | 1984-06-11 | 202 |
| K830468 | MODEL 200 | FTZ | 1983-04-12 | 56 |
| K821834 | MODEL 100 BICARBONATE CONDUCTIVITY | FKQ | 1982-07-02 | 10 |
| K821415 | MODEL 90 BC | FLB | 1982-05-27 | 15 |
| K821414 | MODEL 80 BC | — | 1982-05-27 | 15 |
| K801303 | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST | KDI | 1980-07-28 | 55 |
| K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | FIZ | 1978-08-31 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Western Laboratories Corp..
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.
- Western Advanced Technology, Inc. (6 510(k)s)
- Western Medical, Ltd. (4 510(k)s)
- Western Medical Products, Inc. (3 510(k)s)
- Western M/D, Inc. (2 510(k)s)
- Western Systems Research, Inc. (2 510(k)s)
- Western Clinical Technology Systems, Inc. (1 510(k)s)
- The Western Diagnostics Co. (1 510(k)s)
- Western Dialysis Supplies , Ltd. (1 510(k)s)
- Western Ent. (1 510(k)s)
- Western Graphtec (1 510(k)s)
- Western Medical Equipment Corp. (1 510(k)s)
- Western Medical Research (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Western Laboratories Corp.?
FDA lists 7 510(k) clearances under the applicant name “Western Laboratories Corp.” (first 1978, latest 1984), across 7 product codes in 3 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 Western Laboratories Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Western Laboratories Corp. is 55 days.
Which FDA product codes appear under Western Laboratories Corp.?
The most frequent FDA product codes under this applicant name are FIZ (Meter, Conductivity, Non-Remote, 1); FKQ (System, Dialysate Delivery, Central Multiple Patient, 1); FLB (Meter, Conductivity, Induction, Remote Type, 1).
Next steps
- See all 7 Western Laboratories Corp. clearances with predicates and recalls
- Run predicate analysis for product code FIZ, Western Laboratories Corp.'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.