Covidien, Formerly Nellcor Puritan Bennett, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Covidien, Formerly Nellcor Puritan Bennett, Inc.” (first 2008, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 153 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 162 |
| 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 |
| DQA | Oximeter | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Anesthesiology (4)
- Cardiovascular (1)
Most recent Covidien, Formerly Nellcor Puritan Bennett, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN | DQA | 2013-05-09 | 170 |
| K123002 | VITAL SYNC SYSTEM | MWI | 2013-02-27 | 153 |
| K092847 | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION | CBK | 2010-03-11 | 176 |
| K083693 | PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 | CBK | 2009-04-02 | 111 |
| K082966 | PB 540 VENTILATOR | CBK | 2008-10-31 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Covidien, Formerly Nellcor Puritan Bennett, 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.
- Covidien (224 510(k)s)
- Covidien, Formerly US Surgical A Divison of Tyco H (13 510(k)s)
- Covidien Lp, Formerly Registered AS United States (7 510(k)s)
- Covidien, Formerly Valleylab, A Division of Tyco H (6 510(k)s)
- Covidien Lp, Formerly Registered AS Tyco Healthcar (4 510(k)s)
- Covidien Lp, Formerly Registered AS Kendall (3 510(k)s)
- Covidien, LLC( Formerly Beacon Endoscopic Corp.) (2 510(k)s)
- Covidien, LLC, Formerly Registered AS Tyco Healthca (2 510(k)s)
- Covidien Lp, Formerly Know AS Valleylab, A Divison (2 510(k)s)
- Covidien (Part of Medtronic) (2 510(k)s)
- Covidien (Dba Medtronic) (1 510(k)s)
- Covidien, Formerly Valleylab, (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Covidien, Formerly Nellcor Puritan Bennett, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Covidien, Formerly Nellcor Puritan Bennett, Inc.” (first 2008, latest 2013), across 3 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 Covidien, Formerly Nellcor Puritan Bennett, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covidien, Formerly Nellcor Puritan Bennett, Inc. is 153 days.
Which FDA product codes appear under Covidien, Formerly Nellcor Puritan Bennett, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 3); DQA (Oximeter, 1); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 1).
Next steps
- See all 5 Covidien, Formerly Nellcor Puritan Bennett, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Covidien, Formerly Nellcor Puritan Bennett, 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.