Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien, Formerly Nellcor Puritan Bennett, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
176 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIR | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-05-09 | 170 | 2 |
| K123002 | VITAL SYNC SYSTEM | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-02-27 | 153 | 0 |
| K092847 | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2010-03-11 | 176 | 0 |
| K083693 | PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODE | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009-04-02 | 111 | 0 |
| K082966 | PB 540 VENTILATOR | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2008-10-31 | 25 | 0 |
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