Webster Laboratories, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Webster Laboratories, Inc.” (first 1981, latest 1985), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Webster Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | 1985-12-03 | 113 |
| K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 | 170 |
| K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | 1984-05-09 | 131 |
| K823361 | SWITCHING UNIT ELECTRODE CATHETERS | DRF | 1983-01-14 | 66 |
| K813271 | TEMPERATURE PROBES | KRI | 1981-12-29 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Webster Laboratories, 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.
- Webster Enterprises, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Webster Laboratories, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Webster Laboratories, Inc.” (first 1981, latest 1985), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Webster Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Webster Laboratories, Inc. is 113 days.
Which FDA product codes appear under Webster Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 2); DYG (Catheter, Flow Directed, 1); KRI (Accessory Equipment, Cardiopulmonary Bypass, 1).
Next steps
- See all 5 Webster Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Webster Laboratories, 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.