Lectec Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Lectec Corp.” (first 1977, latest 1996), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 85 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 | 11 | 11 |
| KGX | Tape And Bandage, Adhesive | 8 | 8 |
| GXY | Electrode, Cutaneous | 5 | 5 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (12)
- General and Plastic Surgery (8)
- Neurology (5)
- Radiology (1)
Most recent Lectec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950943 | ULTRA EASE | IYO | 1996-03-07 | 385 |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | KGX | 1993-04-21 | 177 |
| K930258 | TRACET T-6000 | DRX | 1993-04-16 | 87 |
| K923558 | ECG ELECTRODE | DRX | 1993-02-18 | 216 |
| K922959 | ISOPORE TAPE | KGX | 1992-09-11 | 85 |
| K912450 | TRACETS SME 5000 | DRX | 1991-08-28 | 86 |
| K904512 | TRACET AG 4000 | DRX | 1991-01-31 | 121 |
| K893425 | VITATRACE | DRX | 1989-07-14 | 73 |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | KGX | 1988-11-10 | 42 |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | DRX | 1988-07-20 | 55 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lectec Corp..
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 Lectec Corp.?
FDA lists 27 510(k) clearances under the applicant name “Lectec Corp.” (first 1977, latest 1996), across 6 product codes in 4 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 Lectec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lectec Corp. is 85 days.
Which FDA product codes appear under Lectec Corp.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 11); KGX (Tape And Bandage, Adhesive, 8); GXY (Electrode, Cutaneous, 5).
Next steps
- See all 27 Lectec Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Lectec Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.