Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Graham-Field, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
524 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970035 | JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABL | Graham-Field, Inc. | 1997-04-01 | 88 | 0 |
| K961857 | LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 | Graham-Field, Inc. | 1996-07-03 | 50 | 0 |
| K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED | Graham-Field, Inc. | 1994-03-01 | 524 | 0 |
| K904904 | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION | Graham-Field, Inc. | 1991-03-19 | 140 | 0 |
| K901947 | CARDISUNY 501AB | Graham-Field, Inc. | 1990-07-17 | 78 | 0 |
| K901948 | CARDISUNY 501BIII | Graham-Field, Inc. | 1990-07-17 | 78 | 0 |
| K900849 | CARDISUNY, 501BX | Graham-Field, Inc. | 1990-04-04 | 41 | 0 |
| K883224 | UNNA BOOT DRESSING W/CALAMINE | Graham-Field, Inc. | 1989-01-05 | 160 | 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