Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGP — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
196 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | 2025-01-17 | 91 | 0 |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | 2003-09-17 | 196 | 1 |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | 2001-05-03 | 177 | 0 |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | 1994-10-20 | 79 | 0 |
| K910815 | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | 1991-12-10 | 287 | 0 |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Advanced Medical Systems, Inc. | 1991-07-11 | 90 | 0 |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | 1991-03-29 | 88 | 0 |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | 75 | 0 |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | 103 | 0 |
| K901152 | REDYPLATE DISPOSABLE LEG PLATE | Medical Accessories, Inc. | 1990-04-04 | 22 | 0 |
| K872057 | FETAL SCALP ELECTRODE | Medical Accessories, Inc. | 1987-11-16 | 172 | 0 |
| K871079 | FETALFLEX FETAL ELECTRODE | Epcom Medical Systems, Inc. | 1987-07-13 | 117 | 0 |
| K844608 | SURGICRAFT COPELAND DISPOSABLE | A.W. Showell (Surgicraft) , Ltd. | 1985-05-01 | 155 | 0 |
| K822584 | MULTI-PRONG FETAL SCALP ELECTRODE | Kontron Instruments, Inc. | 1983-02-24 | 182 | 0 |
| K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Life Support, Inc. | 1980-09-09 | 21 | 0 |
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Ge Medical Systems Information Technologies | 1980-02-11 | 46 | 1 |
| K771553 | SPIRAL SCALP ELECTRODE, 14499A | Hewlett-Packard Co. | 1977-08-25 | 13 | 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