Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Northgate Research, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
114 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903337 | 1.9 FRENCH LITHOTRIPTER ELECTRODE | Northgate Research, Inc. | 1990-11-16 | 114 | 0 |
| K894704 | 2.5 FRENCH LITHOTRIPTOR ELECTRODE | Northgate Research, Inc. | 1989-10-18 | 85 | 0 |
| K891252 | UROLOGICAL LOOP RETRIEVERS | Northgate Research, Inc. | 1989-03-22 | 14 | 0 |
| K891254 | UROLOGICAL STONE BASKET | Northgate Research, Inc. | 1989-03-22 | 14 | 0 |
| K891253 | UROLOGICAL GRASPING FORCEPS | Northgate Research, Inc. | 1989-03-22 | 14 | 0 |
| K864904 | 3F ELECTRODE | Northgate Research, Inc. | 1987-02-10 | 57 | 0 |
| K852874 | 5F ELECTRODE(LITHOTRIPTOR) | Northgate Research, Inc. | 1985-08-21 | 44 | 0 |
| K802322 | MODEL SD-1 DISINTEGRATOR | Northgate Research, Inc. | 1980-11-10 | 48 | 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