Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HEL · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
134 daysmedian FDA review time
924 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P | Card Guard Scientific Survival , Ltd. | 2001-07-09 | 206 | 0 |
| K010920 | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITOR | Medical Cables, Inc. | 2001-06-22 | 87 | 0 |
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | Corometrics Medical Systems, Inc. | 1998-12-11 | 134 | 0 |
| K971240 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-06-06 | 65 | 0 |
| K930714 | SONICAID MODEL TEAM FECG IUP | Oxford Instruments, Plc. | 1995-08-24 | 924 | 0 |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | Oxford Instruments, Plc. | 1994-12-22 | 505 | 0 |
| K780035 | MINIVISOR | Metrix Teknika, Inc. | 1978-03-06 | 56 | 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