Waters Instruments, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Waters Instruments, Inc.” (first 1981, latest 2006), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| DQA | Oximeter | 3 | 3 |
| KDN | System, Perfusion, Kidney | 2 | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| KDK | Container, Transport, Kidney | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KPH | Catheter, Rectal For Continent Ileostomy | 1 | 1 |
Review panels
Most recent Waters Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | KDK | 2006-01-17 | 64 |
| K042224 | RM3 RENAL PRESERVATION SYSTEM | KDN | 2004-10-22 | 66 |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | KDN | 1997-07-29 | 90 |
| K921519 | OXICOM-2100 | DQA | 1992-10-23 | 206 |
| K911207 | OXICOMPLUS | DQA | 1991-08-26 | 160 |
| K863210 | VELCOM-100 | DPW | 1986-11-26 | 98 |
| K862161 | OSC-80 OXIMETER | DQA | 1986-08-18 | 73 |
| K852909 | MVP - 6000 | BZC | 1985-11-14 | 128 |
| K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT | DXG | 1984-08-23 | 253 |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | DYG | 1984-07-13 | 67 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Waters Instruments, 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 Assoc., Inc. (16 510(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 Instruments, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Waters Instruments, Inc.” (first 1981, latest 2006), across 9 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 Waters Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Waters Instruments, Inc. is 94 days.
Which FDA product codes appear under Waters Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 3); KDN (System, Perfusion, Kidney, 2); BZC (Calculator, Pulmonary Function Data, 1).
Next steps
- See all 12 Waters Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Waters Instruments, 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.