Lori Medical Laboratories, Inc.: FDA clearances and approvals
Lori Medical Laboratories, Inc. has 8 FDA 510(k) clearances (first 1989, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time: 82 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 7 | 7 |
| KHL | Hearing Aid, Master | 1 | 1 |
Review panels
Most recent Lori Medical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973376 | LORI/LORI, LORI-S (LORI STOCK AID) | ESD | 1997-10-14 | 36 |
| K972058 | LORIPRO, LORIPRO II | ESD | 1997-08-15 | 74 |
| K964080 | LORI HEARING AID SIMULATOR | KHL | 1997-01-08 | 89 |
| K952711 | LORI-A | ESD | 1995-07-03 | 19 |
| K940639 | LORI-CIC HEARING AID | ESD | 1994-03-25 | 39 |
| K893723 | LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT | ESD | 1989-09-08 | 114 |
| K893722 | LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT | ESD | 1989-09-08 | 114 |
| K893721 | LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT | ESD | 1989-09-08 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Lori Medical Laboratories, 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 Lori Medical Laboratories, Inc. have?
Lori Medical Laboratories, Inc. has 8 FDA 510(k) clearances (first 1989, latest 1997), across 2 product codes in 1 review panel.
How long does FDA take to clear Lori Medical Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lori Medical Laboratories, Inc.'s cleared 510(k)s is 82 days.
What devices does Lori Medical Laboratories, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 7); KHL (Hearing Aid, Master, 1).
Has Lori Medical Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lori Medical Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 8 Lori Medical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Lori Medical Laboratories, 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.