Waters Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Waters Corporation” (first 1996, latest 2007), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 1 | 1 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 1 | 1 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 1 | 1 |
| LEQ | Detectors, Electrochemical, Liquid Chromatography | 1 | 1 |
| MLM | Enzyme Immunoassay, Tracrolimus | 1 | 1 |
Review panels
Most recent Waters Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | MLM | 2007-05-25 | 147 |
| K980180 | 2700 SAMPLE MANAGER | JQW | 1998-02-12 | 23 |
| K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | KZR | 1997-10-06 | 49 |
| K964588 | WATERS 515 HPLC PUMP (515) | KIE | 1996-11-29 | 14 |
| K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | LEQ | 1996-07-22 | 21 |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | LDM | 1996-07-05 | 74 |
Recalls
openFDA lists no recalls under a recalling firm named Waters Corporation.
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.
- Waters Assoc., Inc. (16 510(k)s)
- Waters Instruments, Inc. (12 510(k)s)
- Waters Medical Systems, LLC (3 510(k)s)
- Waters Chemical Products (2 510(k)s)
- Waters Chromatography Division (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Waters Corporation?
FDA lists 6 510(k) clearances under the applicant name “Waters Corporation” (first 1996, latest 2007), across 6 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 Waters Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Waters Corporation is 36 days.
Which FDA product codes appear under Waters Corporation?
The most frequent FDA product codes under this applicant name are JQW (Station, Pipetting And Diluting, For Clinical Use, 1); KIE (Apparatus, High Pressure Liquid Chromatography, 1); KZR (Chromatography (Liquid, Gel), Clinical Use, 1).
Next steps
- See all 6 Waters Corporation clearances with predicates and recalls
- Run predicate analysis for product code JQW, Waters Corporation'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.