Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kone Instruments, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
83 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873345 | 'MICROLYTE 4/5' | Kone Instruments, Inc. | 1987-09-11 | 23 | 0 |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Kone Instruments, Inc. | 1987-03-13 | 15 | 0 |
| K863466 | M700 STRESS MONITOR | Kone Instruments, Inc. | 1986-12-22 | 105 | 0 |
| K862655 | SIGNA II RESTING ECG ELECTRODE | Kone Instruments, Inc. | 1986-08-06 | 23 | 0 |
| K860767 | MODEL E 600 ELECTROCARDIOGRAPH | Kone Instruments, Inc. | 1986-04-23 | 51 | 0 |
| K853354 | MEDIC 4 | Kone Instruments, Inc. | 1985-10-11 | 60 | 0 |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | Kone Instruments, Inc. | 1984-04-04 | 76 | 0 |
| K830432 | CENTRAL STATION 590 | Kone Instruments, Inc. | 1983-03-24 | 43 | 0 |
| K830433 | PATIENT MONITOR 575 | Kone Instruments, Inc. | 1983-03-24 | 43 | 0 |
| K822952 | 560 | Kone Instruments, Inc. | 1982-11-01 | 28 | 0 |
| K820541 | MICROLYTE | Kone Instruments, Inc. | 1982-05-24 | 83 | 0 |
| K820540 | OLLI 565 | Kone Instruments, Inc. | 1982-04-01 | 30 | 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