Cardiopulmonary Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cardiopulmonary Corp.” (first 1995, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 69 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 | 1 | 326 |
| 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| MSX | System, Network And Communication, Physiological Monitors | 3 | 3 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Anesthesiology (5)
- Cardiovascular (4)
Most recent Cardiopulmonary Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130208 | BERNOULLI ENTERPRISE SOFTWARE | MHX | 2013-12-20 | 326 |
| K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | MOD | 2009-08-14 | 88 |
| K061932 | BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE | MSX | 2006-09-14 | 69 |
| K051283 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | MSX | 2005-06-23 | 37 |
| K020018 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | MSX | 2002-02-21 | 49 |
| K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | MOD | 2001-11-06 | 145 |
| K990429 | MODIFICATION OF VENTURI VENTILATOR | CBK | 1999-02-24 | 13 |
| K982174 | VENTURI VENTILATOR | CBK | 1998-06-24 | 7 |
| K943412 | VENTURI VENTILATOR | CBK | 1995-10-16 | 459 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiopulmonary Corp..
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.
- Cardiopulmonary Instrumentation (1 510(k)s)
- Cardiopulmonary Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiopulmonary Corp.?
FDA lists 9 510(k) clearances under the applicant name “Cardiopulmonary Corp.” (first 1995, latest 2013), 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 Cardiopulmonary Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiopulmonary Corp. is 69 days.
Which FDA product codes appear under Cardiopulmonary Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 3); MSX (System, Network And Communication, Physiological Monitors, 3); MOD (Accessory To Continuous Ventilator (Respirator), 2).
Next steps
- See all 9 Cardiopulmonary Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Cardiopulmonary Corp.'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.