Gould, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Gould, Inc.” (first 1976, latest 1991), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 6 | 6 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 | 4 |
| KRB | Probe, Thermodilution | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
Plus 6 more product codes.
Review panels
- Cardiovascular (29)
- Anesthesiology (2)
Most recent Gould, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | DRR | 1991-07-22 | 82 |
| K861092 | MODEL SP1465 CARDIAC OUTPUT COMPUTER | DXG | 1986-08-18 | 147 |
| K860805 | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 | DQO | 1986-05-08 | 65 |
| K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR | DRS | 1986-02-26 | 64 |
| K854403 | MODEL 2120 SPIROSCREEN | BZG | 1986-01-14 | 75 |
| K851486 | GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX | DRS | 1985-10-17 | 185 |
| K850114 | C/PES 9201, ECG STRESS TESTING SYS | DRT | 1985-02-22 | 39 |
| K850113 | C/PES 9103, ECG STRESS TESTING SYSTEM | DRT | 1985-02-08 | 25 |
| K843555 | CARDIAC COMPUTER SP1445 | DXG | 1985-02-01 | 144 |
| K843969 | MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER | DXO | 1985-01-23 | 104 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gould, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gould, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Gould, Inc.” (first 1976, latest 1991), across 16 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 Gould, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gould, Inc. is 39 days.
Which FDA product codes appear under Gould, Inc.?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 6); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 4); KRB (Probe, Thermodilution, 4).
Next steps
- See all 31 Gould, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRS, Gould, 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.