Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulmonetic Systems, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
152 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | Pulmonetic Systems, Inc. | 2009-03-18 | 96 | 1 |
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007-08-01 | 152 | 4 |
| K060647 | LTV 1200 VENTILATOR | Pulmonetic Systems, Inc. | 2006-05-25 | 73 | 0 |
| K060549 | AUTOMOBILE LIGHTER POWER CORD | Pulmonetic Systems, Inc. | 2006-05-04 | 63 | 0 |
| K051767 | LTV 1000 VENTILATOR | Pulmonetic Systems, Inc. | 2005-07-29 | 29 | 0 |
| K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | Pulmonetic Systems, Inc. | 2004-06-03 | 66 | 0 |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR | Pulmonetic Systems, Inc. | 2004-04-29 | 58 | 8 |
| K032226 | LTV-1000 VENTILATOR | Pulmonetic Systems, Inc. | 2003-10-16 | 87 | 1 |
| K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) | Pulmonetic Systems, Inc. | 2001-03-20 | 19 | 4 |
| K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 | Pulmonetic Systems, Inc. | 2000-10-11 | 26 | 12 |
| K984056 | LTV 1000 | Pulmonetic Systems, Inc. | 1999-04-12 | 150 | 12 |
| K981371 | LTV 1000 VENTILATOR | Pulmonetic Systems, Inc. | 1998-10-30 | 197 | 12 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda