Smiths Medical Pm, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smiths Medical Pm, Inc.” (first 2007, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 116 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 ICU Medical, 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 | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Smiths Medical Pm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083557 | BCI WW1030 PULSE OXIMETER | DQA | 2009-05-01 | 150 |
| K090205 | BCI WW1021 PC APPLICATION | DQA | 2009-04-28 | 90 |
| K083787 | BCI WW1000 PULSE OXIMETER, MODEL WW1000 | DQA | 2009-04-15 | 117 |
| K083705 | BCI WW1020 PULSE OXIMETER, MODEL WW1020 | DQA | 2009-04-09 | 115 |
| K070732 | BCI AUTOCON 3304 DIGITAL PULSE OXIMETER | DQA | 2007-07-09 | 116 |
Recalls
49 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2010-01-15.
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.
- Smiths Medical Asd, Inc. (52 510(k)s)
- Smiths Industries Medical Systems, Inc. (22 510(k)s)
- Smiths Medical MD, Inc. (20 510(k)s)
- Smiths Medical International , Ltd. (4 510(k)s)
- Smiths Medical (3 510(k)s)
- Smiths Medical Ads, Inc. (2 510(k)s)
- Smiths Medical International Ltd., Luton (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smiths Medical Pm, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Smiths Medical Pm, Inc.” (first 2007, latest 2009), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smiths Medical Pm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smiths Medical Pm, Inc. is 116 days.
Which FDA product codes appear under Smiths Medical Pm, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 5).
Next steps
- See all 5 Smiths Medical Pm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Smiths Medical Pm, 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.