Canadian Monaghan , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Canadian Monaghan , Ltd.” (first 1987, latest 1993), across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Canadian Monaghan , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931394 | CM5000R REMOTE INDICATOR | CAP | 1993-07-01 | 104 |
| K931287 | CM7000 REMOTE INDICATOR | CAP | 1993-07-01 | 111 |
| K925673 | AIRWAY PRESSURE MONITOR CM 5000 NGAN | CAP | 1993-06-09 | 211 |
| K873953 | CM 5000R REMOTE AIRWAY PRESSURE | CAP | 1987-10-27 | 29 |
| K871083 | CM 5000 MONITOR AIRWAY PRESSURE | CAP | 1987-04-08 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Canadian Monaghan , Ltd..
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.
- Canadian Bioclinical, Ltd. (4 510(k)s)
- Canadian Pioneer Medical Technology Corporation (3 510(k)s)
- Canadian Medical Products (2 510(k)s)
- Canadian Pioneer Medical Technology Corporation (Cpmt Laser) (2 510(k)s)
- Canadian Posture and Seating Centre, Inc. (2 510(k)s)
- Canadian Technical Tape, Ltd. (2 510(k)s)
- Canadian Medical Brush, Inc. (1 510(k)s)
- Canadian Theatre Products , Ltd. (1 510(k)s)
- Canadian Wheelchair (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Canadian Monaghan , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Canadian Monaghan , Ltd.” (first 1987, latest 1993), 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 Canadian Monaghan , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Canadian Monaghan , Ltd. is 104 days.
Which FDA product codes appear under Canadian Monaghan , Ltd.?
The most frequent FDA product codes under this applicant name are CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 5).
Next steps
- See all 5 Canadian Monaghan , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAP, Canadian Monaghan , Ltd.'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.