Orange Medical Instruments, Inc.: FDA clearances and approvals
Orange Medical Instruments, Inc. has 12 FDA 510(k) clearances (first 1982, latest 1986), across 7 product codes in 3 review panels. Median 510(k) review time: 64 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| FMF | Syringe, Piston | 3 | 3 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
Review panels
- General Hospital (6)
- Clinical Chemistry (4)
- Anesthesiology (2)
Most recent Orange Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860808 | CONTINUCATH | CCE | 1986-03-13 | 9 |
| K851822 | BETA SCAN TRENDS METER | CGA | 1985-10-03 | 160 |
| K844796 | MICRO-BETA U100 SYRINGE | FMF | 1984-12-18 | 7 |
| K843882 | TRENDS LANCET | KMK | 1984-11-05 | 34 |
| K841369 | BETA SCAN DRYSTIX | CGA | 1984-08-23 | 142 |
| K833705 | BETAJECT BD U100 | FMI | 1984-05-09 | 204 |
| K833706 | CLICK-COUNT U100 INSULIN SYRINGE | FMF | 1984-04-05 | 170 |
| K832691 | BETA SCAN REAGENT STRIP | CGA | 1983-11-14 | 96 |
| K832793 | NEOCATH 1000 W/HEPCOTE | CCE | 1983-09-26 | 38 |
| K831897 | BETA I PROGRAMMABLE INFUSION PUMP | FRN | 1983-08-12 | 59 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orange Medical Instruments, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Orange Medical Instruments, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Orange Medical Instruments, Inc. have?
Orange Medical Instruments, Inc. has 12 FDA 510(k) clearances (first 1982, latest 1986), across 7 product codes in 3 review panels.
How long does FDA take to clear Orange Medical Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Orange Medical Instruments, Inc.'s cleared 510(k)s is 64 days.
What devices does Orange Medical Instruments, Inc. make?
Its most frequent FDA product codes are CGA (Glucose Oxidase, Glucose, 3); FMF (Syringe, Piston, 3); CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, 2).
Has Orange Medical Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orange Medical Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 12 Orange Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Orange Medical Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.