Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Acoustics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
276 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873640 | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1987-12-07 | 89 | 0 |
| K864278 | DS-II DIGITAL SONOGRAPHY SYSTEM | Intl. Acoustics, Inc. | 1987-06-10 | 223 | 0 |
| K864429 | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | 1987-05-12 | 181 | 0 |
| K860814 | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1986-12-05 | 276 | 0 |
| K844997 | IAI PROGRAM-COMPUTER PROGRAM | Intl. Acoustics, Inc. | 1985-04-09 | 104 | 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