Lead-Lok, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lead-Lok, Inc.” (first 1989, latest 2001), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 205 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Cardiovascular (3)
- Neurology (1)
- Radiology (1)
Most recent Lead-Lok, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010431 | LEAD-LOK REUSABLE TENS/ NMES ELECTRODES | GXY | 2001-09-06 | 205 |
| K911529 | BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG | DRX | 1992-11-09 | 585 |
| K911518 | BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM | DRX | 1992-11-09 | 585 |
| K903729 | GOLD GATORS | DRY | 1990-09-14 | 29 |
| K895100 | ECHO GEL (RAINFOREST) | ITX | 1989-11-03 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Lead-Lok, 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 Lead-Lok, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Lead-Lok, Inc.” (first 1989, latest 2001), across 4 product codes in 3 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 Lead-Lok, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lead-Lok, Inc. is 205 days.
Which FDA product codes appear under Lead-Lok, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 2); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 1); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 5 Lead-Lok, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Lead-Lok, 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.