Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Colin Medical Instruments Corp. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
484 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032857 | PRESS-MATE BX-10 VITAL SIGN MONITOR | Colin Medical Instruments Corp. | 2004-02-04 | 145 | 0 |
| K022537 | PRESS-MATE PM-2100 VITAL SIGN MONITOR | Colin Medical Instruments Corp. | 2002-09-13 | 43 | 0 |
| K973637 | PRESS-MATE ADVANTAGE | Colin Medical Instruments Corp. | 1998-09-25 | 366 | 0 |
| K922668 | PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM | Colin Medical Instruments Corp. | 1997-01-29 | 1700 | 0 |
| K942871 | PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SY | Colin Medical Instruments Corp. | 1994-10-17 | 122 | 0 |
| K921048 | BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST | Colin Medical Instruments Corp. | 1993-07-01 | 484 | 0 |
| K900247 | CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM | Colin Medical Instruments Corp. | 1990-07-17 | 181 | 0 |
| K890876 | BP-8800 BLOOD PRESSURE MONITOR | Colin Medical Instruments Corp. | 1989-06-22 | 121 | 0 |
| K884822 | MODEL OX-1 OXYGEN SATURATION MODULE | Colin Medical Instruments Corp. | 1989-03-02 | 104 | 0 |
| K884885 | BP-408 MARK II | Colin Medical Instruments Corp. | 1989-02-23 | 93 | 0 |
| K884896 | BP-308 MARK II | Colin Medical Instruments Corp. | 1989-02-23 | 93 | 0 |
| K874692 | PULSEMATE BX-5 | Colin Medical Instruments Corp. | 1988-02-02 | 78 | 0 |
| K872355 | COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 | Colin Medical Instruments Corp. | 1987-09-15 | 89 | 0 |
| K864654 | COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR | Colin Medical Instruments Corp. | 1987-02-10 | 74 | 0 |
| K854481 | COLIN ELECTRONICS CO., LTD. STBP 680 | Colin Medical Instruments Corp. | 1986-06-09 | 214 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda