Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orange Medical Instruments, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
170 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860808 | CONTINUCATH | Orange Medical Instruments, Inc. | 1986-03-13 | 9 | 0 |
| K851822 | BETA SCAN TRENDS METER | Orange Medical Instruments, Inc. | 1985-10-03 | 160 | 0 |
| K844796 | MICRO-BETA U100 SYRINGE | Orange Medical Instruments, Inc. | 1984-12-18 | 7 | 0 |
| K843882 | TRENDS LANCET | Orange Medical Instruments, Inc. | 1984-11-05 | 34 | 0 |
| K841369 | BETA SCAN DRYSTIX | Orange Medical Instruments, Inc. | 1984-08-23 | 142 | 0 |
| K833705 | BETAJECT BD U100 | Orange Medical Instruments, Inc. | 1984-05-09 | 204 | 0 |
| K833706 | CLICK-COUNT U100 INSULIN SYRINGE | Orange Medical Instruments, Inc. | 1984-04-05 | 170 | 0 |
| K832691 | BETA SCAN REAGENT STRIP | Orange Medical Instruments, Inc. | 1983-11-14 | 96 | 0 |
| K832793 | NEOCATH 1000 W/HEPCOTE | Orange Medical Instruments, Inc. | 1983-09-26 | 38 | 0 |
| K831897 | BETA I PROGRAMMABLE INFUSION PUMP | Orange Medical Instruments, Inc. | 1983-08-12 | 59 | 0 |
| K831523 | BETA SCAN NORMAL CONTROL SOLUTION | Orange Medical Instruments, Inc. | 1983-07-19 | 68 | 0 |
| K822928 | DISPOSABLE MICRO-INFUSION SYSTEM | Orange Medical Instruments, Inc. | 1982-10-26 | 22 | 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