Laclede, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Laclede, Inc.” (first 2006, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 210 days. Since 2017 the median was 210 days, against 143 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 274 |
| 2016 | 0 | — |
| 2017 | 1 | 227 |
| 2018 | 1 | 210 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 58 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laclede, Inc. took a median 210 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LFD | Saliva, Artificial | 3 | 3 |
| NUC | Lubricant, Personal | 2 | 2 |
Review panels
- Dental (3)
- Obstetrics and Gynecology (2)
Most recent Laclede, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | LFD | 2024-04-19 | 58 |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | LFD | 2018-10-11 | 210 |
| K162235 | LUVENA VAGINAL MOISTURIZER & LUBRICANT | NUC | 2017-03-24 | 227 |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | NUC | 2015-12-29 | 274 |
| K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 | 74 |
Recalls
openFDA lists no recalls under a recalling firm named Laclede, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Laclede, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Laclede, Inc.” (first 2006, latest 2024), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Laclede, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laclede, Inc. is 210 days. Since 2017: 210 days, versus 143 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Laclede, Inc.?
The most frequent FDA product codes under this applicant name are LFD (Saliva, Artificial, 3); NUC (Lubricant, Personal, 2).
Next steps
- See all 5 Laclede, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFD, Laclede, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.