Healthdyne Cardiovascular, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Healthdyne Cardiovascular, Inc.” (first 1989, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| KXO | Monitor, Pressure, Intrauterine | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 | 1 |
Review panels
Most recent Healthdyne Cardiovascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | HIO | 1990-07-25 | 107 |
| K901382 | ISOFLO(TM) HIGH PRESSURE INJECTION LINES | DXT | 1990-07-19 | 119 |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | KXO | 1990-06-01 | 86 |
| K900665 | DRESSING CHANGE KIT | FXX | 1990-05-14 | 90 |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | KXO | 1989-12-22 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Healthdyne Cardiovascular, 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.
- Healthdyne, Inc. (35 510(k)s)
- Healthdyne Technologies, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthdyne Cardiovascular, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Healthdyne Cardiovascular, Inc.” (first 1989, latest 1990), across 4 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 Healthdyne Cardiovascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthdyne Cardiovascular, Inc. is 90 days.
Which FDA product codes appear under Healthdyne Cardiovascular, Inc.?
The most frequent FDA product codes under this applicant name are KXO (Monitor, Pressure, Intrauterine, 2); DXT (Injector And Syringe, Angiographic, 1); FXX (Mask, Surgical, 1).
Next steps
- See all 5 Healthdyne Cardiovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KXO, Healthdyne Cardiovascular, 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.