Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HCB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
1321 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911820 | GED (GRADUATED ELECTRONIC DECELERATOR | Behavior Research Institute, Inc. | 1994-12-05 | 1321 | 0 |
| K871158 | SIBIS REMOTE ACTUATOR | Human Technologies, Inc. | 1987-05-29 | 66 | 0 |
| K853178 | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM | Oxford Medilog, Inc. | 1986-02-28 | 213 | 0 |
| K820622 | ELECTROSTIMULI AVERSION MACHINE | Michael R. Kiss | 1982-04-09 | 32 | 0 |
| K790738 | HABITSABATER | Jackson Ent. | 1979-06-20 | 65 | 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