Waters Assoc., Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Waters Assoc., Inc.” (first 1976, latest 1981), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| KIE | Apparatus, High Pressure Liquid Chromatography | 4 | 4 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DXM | Densitometer | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (6)
- Clinical Toxicology (4)
- Clinical Chemistry (3)
- Anesthesiology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Waters Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL | JJQ | 1981-07-27 | 14 |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | DYG | 1980-10-31 | 24 |
| K801852 | MRM-2 OXYGEN CONSUMPTION MONITOR | BZL | 1980-08-20 | 16 |
| K801431 | PAN-AM MYELOGRAM TRAY | FMI | 1980-08-12 | 55 |
| K791661 | SYSTEM CONTROLLER 720 SERIES | KIE | 1979-09-24 | 34 |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | KRB | 1979-06-22 | 18 |
| K790145 | SOLVENT DELIVERY SYSTEM | KIE | 1979-02-15 | 28 |
| K782175 | CARTRIDGE HOLDER, RCM 100 | KIE | 1979-02-15 | 49 |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | DXG | 1979-01-29 | 97 |
| K781915 | DATA MODULE | KIE | 1979-01-10 | 57 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Waters Assoc., 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.
- Waters Instruments, Inc. (12 510(k)s)
- Waters Corporation (6 510(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 Assoc., Inc.?
FDA lists 16 510(k) clearances under the applicant name “Waters Assoc., Inc.” (first 1976, latest 1981), across 12 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 Waters Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Waters Assoc., Inc. is 31 days.
Which FDA product codes appear under Waters Assoc., Inc.?
The most frequent FDA product codes under this applicant name are KIE (Apparatus, High Pressure Liquid Chromatography, 4); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 2); BZL (Computer, Oxygen-Uptake, 1).
Next steps
- See all 16 Waters Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIE, Waters Assoc., 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.