Colin Medical Instruments Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Colin Medical Instruments Corp.” (first 1986, latest 2004), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 121 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 9 |
| DQA | Oximeter | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (13)
- Anesthesiology (2)
Most recent Colin Medical Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032857 | PRESS-MATE BX-10 VITAL SIGN MONITOR | DXN | 2004-02-04 | 145 |
| K022537 | PRESS-MATE PM-2100 VITAL SIGN MONITOR | MWI | 2002-09-13 | 43 |
| K973637 | PRESS-MATE ADVANTAGE | DXN | 1998-09-25 | 366 |
| K922668 | PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM | MHX | 1997-01-29 | 1700 |
| K942871 | PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM | DXN | 1994-10-17 | 122 |
| K921048 | BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST | DXN | 1993-07-01 | 484 |
| K900247 | CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM | DXN | 1990-07-17 | 181 |
| K890876 | BP-8800 BLOOD PRESSURE MONITOR | DRT | 1989-06-22 | 121 |
| K884822 | MODEL OX-1 OXYGEN SATURATION MODULE | DQA | 1989-03-02 | 104 |
| K884896 | BP-308 MARK II | DPS | 1989-02-23 | 93 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Colin Medical Instruments Corp..
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.
- Colin Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Colin Medical Instruments Corp.?
FDA lists 15 510(k) clearances under the applicant name “Colin Medical Instruments Corp.” (first 1986, latest 2004), 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 Colin Medical Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Colin Medical Instruments Corp. is 121 days.
Which FDA product codes appear under Colin Medical Instruments Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9); DQA (Oximeter, 2); DPS (Electrocardiograph, 1).
Next steps
- See all 15 Colin Medical Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Colin Medical Instruments Corp.'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.