Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Protek Medical Products, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
223 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973958 | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | Protek Medical Products, Inc. | 1998-01-22 | 98 | 0 |
| K973622 | TRANSDUCER POSITIONER | Protek Medical Products, Inc. | 1997-11-26 | 64 | 0 |
| K970889 | ULTRASOUND TRANSDUCER DRAPE | Protek Medical Products, Inc. | 1997-10-20 | 223 | 0 |
| K970893 | ULTRASOUND TRANSDUCER DRAPE | Protek Medical Products, Inc. | 1997-10-20 | 223 | 0 |
| K973362 | NEEDLE GUIDE/GRID | Protek Medical Products, Inc. | 1997-10-01 | 23 | 0 |
| K970885 | ULTRASOUND SYSTEMS DRAPE | Protek Medical Products, Inc. | 1997-09-22 | 195 | 0 |
| K970891 | DRAPE, SURGICAL-LATEX | Protek Medical Products, Inc. | 1997-08-22 | 164 | 0 |
| K971722 | TRANS VAGINAL NEEDLE GUIDE | Protek Medical Products, Inc. | 1997-07-10 | 62 | 0 |
| K971115 | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUI | Protek Medical Products, Inc. | 1997-06-13 | 78 | 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