Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JHG — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
163 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061549 | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | 2006-10-18 | 135 | 0 |
| K871593 | TDXR FETAL LUNG MATURITY | Abbott Laboratories | 1987-07-20 | 87 | 0 |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | Hana Biologics, Inc. | 1984-05-25 | 163 | 0 |
| K822150 | AMNISTAT-FLM | Hana Biologics, Inc. | 1982-10-21 | 91 | 0 |
| K813216 | SECURE FDI TEST KIT | Beckman Instruments, Inc. | 1981-12-17 | 38 | 0 |
| K811588 | HELENA FETAL-TEK 200 METHOD | Helena Laboratories | 1981-06-25 | 17 | 0 |
| K790798 | FETAL MATURITY TEST PROCEDURE | Helena Laboratories | 1979-06-05 | 49 | 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