Pulmonetic Systems, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pulmonetic Systems, Inc.” (first 1998, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 12 | 12 |
Review panels
- Anesthesiology (12)
Most recent Pulmonetic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | CBK | 2009-03-18 | 96 |
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | CBK | 2007-08-01 | 152 |
| K060647 | LTV 1200 VENTILATOR | CBK | 2006-05-25 | 73 |
| K060549 | AUTOMOBILE LIGHTER POWER CORD | CBK | 2006-05-04 | 63 |
| K051767 | LTV 1000 VENTILATOR | CBK | 2005-07-29 | 29 |
| K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | CBK | 2004-06-03 | 66 |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR | CBK | 2004-04-29 | 58 |
| K032226 | LTV-1000 VENTILATOR | CBK | 2003-10-16 | 87 |
| K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) | CBK | 2001-03-20 | 19 |
| K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 | CBK | 2000-10-11 | 26 |
2 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-11-09.
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 Pulmonetic Systems, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Pulmonetic Systems, Inc.” (first 1998, latest 2009), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pulmonetic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pulmonetic Systems, Inc. is 70 days.
Which FDA product codes appear under Pulmonetic Systems, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 12).
Next steps
- See all 12 Pulmonetic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Pulmonetic Systems, 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.