Nellcor Puritan Bennett, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Nellcor Puritan Bennett, Inc.” (first 1996, latest 2007), plus 1 PMA decision, across 14 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| DQA | Oximeter | 19 | 19 |
| CBK | Ventilator, Continuous, Facility Use | 5 | 5 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 3 | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| DWJ | System, Thermal Regulating | 2 | 2 |
| LRK | Device, Anti-Snoring | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Anesthesiology (38)
- Cardiovascular (4)
- Dental (2)
Most recent Nellcor Puritan Bennett, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070899 | PURITAN BENNETT LEGENDAIR XL2 | CBK | 2007-12-13 | 255 |
| K070408 | DURAMAX REUSABLE OXIMETRY SENSOR | DQA | 2007-05-25 | 102 |
| K060576 | NELLCOR OXIMAX N-600X PULSE OXIMETER | DQA | 2006-08-14 | 161 |
| K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR | DQA | 2006-01-10 | 238 |
| K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P | DQA | 2005-11-10 | 91 |
| K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER | DQA | 2005-08-11 | 79 |
| K050072 | GOODKNIGHT 425ST | BZD | 2005-06-13 | 152 |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | NLF | 2004-12-13 | 357 |
| K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE | JOH | 2003-11-14 | 247 |
| K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | DQA | 2003-05-23 | 59 |
33 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880013 | PMA | INFANT STAR HIGH FREQUENCY VENTILATOR | 1990-01-19 |
Recalls
11 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2007-03-12.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Nellcor Puritan Bennett, Inc. (a text match, not an official crosswalk):
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.
- Nellcor, Inc. (18 510(k)s)
- Nellcor Puritan Bennett France Dvpt. (2 510(k)s)
- Nellcor Puritan Bennett (Melville) , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nellcor Puritan Bennett, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Nellcor Puritan Bennett, Inc.” (first 1996, latest 2007), plus 1 PMA decision, across 14 product codes in 3 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 Nellcor Puritan Bennett, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nellcor Puritan Bennett, Inc. is 89 days.
Which FDA product codes appear under Nellcor Puritan Bennett, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 19); CBK (Ventilator, Continuous, Facility Use, 5); BTM (Ventilator, Emergency, Manual (Resuscitator), 3).
Next steps
- See all 43 Nellcor Puritan Bennett, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, 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.