Nellcor, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Nellcor, Inc.” (first 1982, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 | 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 | 11 | 11 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 1 |
| DPZ | Oximeter, Ear | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Anesthesiology (15)
- Cardiovascular (3)
Most recent Nellcor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953472 | NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR | DXN | 1995-10-20 | 88 |
| K952316 | NELLCOR SYMPHONY N-3000 PULSE OXIMETER | DQA | 1995-08-17 | 92 |
| K952222 | NELLCOR N-20PA PORTABLE PULSE OXIMETER | DQA | 1995-08-15 | 95 |
| K942347 | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 | DQA | 1995-05-12 | 360 |
| K945947 | NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER | DXN | 1995-03-08 | 92 |
| K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | DPZ | 1994-10-17 | 20 |
| K944400 | PEDI-CAP | CCK | 1994-09-27 | 19 |
| K915494 | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 | CCK | 1993-08-06 | 606 |
| K915699 | NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 | DQA | 1993-05-27 | 521 |
| K913695 | NELLCOR(R) N-180 PULSE OXIMETER | DQA | 1991-11-13 | 86 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nellcor, 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.
- Nellcor Puritan Bennett, Inc. (43 510(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, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Nellcor, Inc.” (first 1982, latest 1995), across 6 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 Nellcor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nellcor, Inc. is 87 days.
Which FDA product codes appear under Nellcor, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 11); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Next steps
- See all 18 Nellcor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Nellcor, 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.