Lumiscope Co., Inc.: FDA clearances and approvals
Lumiscope Co., Inc. has 13 FDA 510(k) clearances (first 1988, latest 2003), across 10 product codes in 5 review panels. Median 510(k) review time: 88 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Neurology (5)
- General Hospital (3)
- Anesthesiology (2)
- Physical Medicine (2)
- Cardiovascular (1)
Most recent Lumiscope Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032714 | CARDICARE MODEL MT-301F & MT-301C | FLL | 2003-10-22 | 50 |
| K954792 | LUMISCOPE MODEL 2018 THERMOMETER | FLL | 1996-06-21 | 247 |
| K931768 | INTERFERENTIAL CURRENT THERAPY UNIT | LIH | 1994-02-23 | 321 |
| K925054 | INFRARED LAMP | ILY | 1993-06-29 | 266 |
| K924081 | LUMISONIC | CAF | 1992-11-09 | 88 |
| K920099 | GYMMAN | DRT | 1992-03-09 | 60 |
| K901849 | LUMISCOPE EMS 8000 | IPF | 1990-08-24 | 122 |
| K901096 | LUMISCOPE ALTERNATING PRESSURE PAD & PUMP | FNM | 1990-08-21 | 167 |
| K901726 | LUMISCOPE MICRO 100 | GZJ | 1990-08-14 | 120 |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | GXY | 1990-06-18 | 59 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lumiscope Co., 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 Lumiscope Co., Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Lumiscope Co., Inc. have?
Lumiscope Co., Inc. has 13 FDA 510(k) clearances (first 1988, latest 2003), across 10 product codes in 5 review panels.
How long does FDA take to clear Lumiscope Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lumiscope Co., Inc.'s cleared 510(k)s is 88 days.
What devices does Lumiscope Co., Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); FLL (Continuous Measurement Thermometer, 2); BTI (Compressor, Air, Portable, 1).
Has Lumiscope Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lumiscope Co., Inc. Related entities may recall under other names.
Next steps
- See all 13 Lumiscope Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Lumiscope Co., 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.