Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Farrall Instruments, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
690 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K936115 | CAT-600 PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | 1995-01-10 | 690 | 0 |
| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | 1995-01-10 | 365 | 0 |
| K821723 | BI-4520 DUAL IMPEDOMETER | Farrall Instruments, Inc. | 1982-09-15 | 98 | 0 |
| K821664 | PP-100, PERSONAL PERINEOMETER | Farrall Instruments, Inc. | 1982-07-13 | 46 | 0 |
| K792305 | A SLEEP ASSESSMENT DEVICE | Farrall Instruments, Inc. | 1979-12-20 | 34 | 0 |
| K781634 | VISUALAX | Farrall Instruments, Inc. | 1978-10-03 | 11 | 0 |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Farrall Instruments, Inc. | 1976-07-20 | 14 | 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