East Texas Lighthouse For the Blind: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “East Texas Lighthouse For the Blind” (first 1985, latest 1988), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 21 days. 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 | 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent East Texas Lighthouse For the Blind 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883376 | STERILIZATION WRAP TYPE 22,44,77 | FRG | 1988-09-28 | 50 |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | LRP | 1988-07-18 | 48 |
| K863733 | TOWEL PACK, SURGICAL | — | 1986-10-14 | 21 |
| K862062 | NONWOVEN SURGICAL DRAPE PACK | KKX | 1986-06-10 | 11 |
| K850067 | MEDICAL, DISPOSABLE BEDDING | KME | 1985-04-19 | 101 |
| K850811 | PAD, PRE-OPERATIVE PREPARATION | KME | 1985-03-21 | 21 |
| K850016 | TOWEL PACK, SURGICAL | — | 1985-01-23 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named East Texas Lighthouse For the Blind.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- East End Medical I, LLC (2 510(k)s)
- East Health Development Group, Inc. (1 510(k)s)
- East West Instruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under East Texas Lighthouse For the Blind?
FDA lists 7 510(k) clearances under the applicant name “East Texas Lighthouse For the Blind” (first 1985, latest 1988), across 5 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 East Texas Lighthouse For the Blind?
The median time from FDA receipt to decision across 510(k)s cleared under the name East Texas Lighthouse For the Blind is 21 days.
Which FDA product codes appear under East Texas Lighthouse For the Blind?
The most frequent FDA product codes under this applicant name are KME (Bedding, Disposable, Medical, 2); FRG (Wrap, Sterilization, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 7 East Texas Lighthouse For the Blind clearances with predicates and recalls
- Run predicate analysis for product code KME, East Texas Lighthouse For the Blind'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.