Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Output, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800360 | OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 | Output, Inc. | 1980-02-29 | 9 | 0 |
| K781115 | PRINTER, DIGITAL | Output, Inc. | 1978-10-06 | 95 | 0 |
| K780356 | OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 | Output, Inc. | 1978-05-31 | 86 | 0 |
| K770987 | NERVE STIMULATOR, MOLEL NO. FB-800 | Output, Inc. | 1977-06-14 | 14 | 0 |
| K760614 | PERIPHERAL NERVE STIMULATOR | Output, Inc. | 1976-11-19 | 70 | 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