Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Howard Instruments, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
279 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063104 | FOX MEDICAL DIODE LASER SYSTEM 810NM | Howard Instruments, Inc. | 2007-05-16 | 279 | 0 |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | 2003-06-17 | 83 | 0 |
| K980985 | SCMD-1000 | Howard Instruments, Inc. | 1998-05-01 | 45 | 0 |
| K974598 | MICROKERATOME OR THE MATE | Howard Instruments, Inc. | 1998-04-22 | 134 | 0 |
| K972727 | CBALK-1000 BLADE | Howard Instruments, Inc. | 1997-10-10 | 81 | 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