Lumex, Inc.: FDA clearances and approvals
Lumex, Inc. has 8 FDA 510(k) clearances (first 1990, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time: 134 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | 3 | 3 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
Review panels
Most recent Lumex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963674 | LUMEX AIR | FNM | 1997-01-10 | 119 |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | FNM | 1996-07-18 | 48 |
| K953675 | ALTADYNE | FNM | 1995-09-28 | 52 |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | IOR | 1995-05-12 | 203 |
| K945257 | 577ES (ERGOSENSE) | INO | 1995-04-26 | 180 |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) | IOR | 1994-10-17 | 28 |
| K923977 | AKROTECH 4000 | IOQ | 1993-02-12 | 189 |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | FPO | 1990-02-22 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Lumex, 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.
Frequently asked questions
How many FDA 510(k) clearances does Lumex, Inc. have?
Lumex, Inc. has 8 FDA 510(k) clearances (first 1990, latest 1997), across 5 product codes in 2 review panels.
How long does FDA take to clear Lumex, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lumex, Inc.'s cleared 510(k)s is 134 days.
What devices does Lumex, Inc. make?
Its most frequent FDA product codes are FNM (Mattress, Air Flotation, Alternating Pressure, 3); IOR (Wheelchair, Mechanical, 2); FPO (Stretcher, Wheeled, 1).
Has Lumex, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lumex, Inc. Related entities may recall under other names.
Next steps
- See all 8 Lumex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNM, Lumex, 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.