Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FSH · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
65 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884876 | S 4 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-12-15 | 24 | 0 |
| K883578 | S 21 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-09-13 | 22 | 0 |
| K821921 | STAND, SURG. INSTRUMENT & DRESSING | Emerson-Sack-Warner Corp. | 1982-07-30 | 31 | 0 |
| K813337 | SKINNY CHIBA NEEDLE & TRAY | American Pharmaseal Div. Ahsc | 1982-01-28 | 65 | 0 |
| K813338 | BIOPSY NEEDLES & TRAYS | American Pharmaseal Div. Ahsc | 1982-01-28 | 65 | 1 |
| K813335 | PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY | American Pharmaseal Div. Ahsc | 1982-01-08 | 45 | 0 |
| K780759 | MODEL 902 STAND | Applied Medical Research | 1978-05-19 | 11 | 0 |
| K772188 | FSH RIA KIT (125I) | Diagnostic Products Corp. | 1977-12-22 | 27 | 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