Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amplaid USA, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
155 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861014 | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) | Amplaid USA, Inc. | 1986-08-20 | 155 | 0 |
| K832510 | EVOKED POTENTIALS SYSTEM MK10 | Amplaid USA, Inc. | 1983-11-25 | 121 | 0 |
| K810482 | SOMATOSENSORY STIMULATOR | Amplaid USA, Inc. | 1981-04-29 | 65 | 0 |
| K810473 | MK6 ERA SYSTEM | Amplaid USA, Inc. | 1981-04-29 | 65 | 0 |
| K810481 | VISUAL PATTERN REVERSAL GEN. & PHOTIC S. | Amplaid USA, Inc. | 1981-03-11 | 16 | 0 |
| K802963 | 101, 151, 161 PORTABLE AUDIOMETERS | Amplaid USA, Inc. | 1980-12-19 | 28 | 0 |
| K802097 | SELF-RECORDING ADMITTANCE METER 709 | Amplaid USA, Inc. | 1980-10-10 | 38 | 0 |
| K781667 | AMPLAID MARK 4 AND MARK 5 | Amplaid USA, Inc. | 1978-11-03 | 39 | 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