Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lectec Corp. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
273 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950943 | ULTRA EASE | Lectec Corp. | 1996-03-07 | 385 | 0 |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | Lectec Corp. | 1993-04-21 | 177 | 0 |
| K930258 | TRACET T-6000 | Lectec Corp. | 1993-04-16 | 87 | 0 |
| K923558 | ECG ELECTRODE | Lectec Corp. | 1993-02-18 | 216 | 0 |
| K922959 | ISOPORE TAPE | Lectec Corp. | 1992-09-11 | 85 | 0 |
| K912450 | TRACETS SME 5000 | Lectec Corp. | 1991-08-28 | 86 | 0 |
| K904512 | TRACET AG 4000 | Lectec Corp. | 1991-01-31 | 121 | 0 |
| K893425 | VITATRACE | Lectec Corp. | 1989-07-14 | 73 | 0 |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | Lectec Corp. | 1988-11-10 | 42 | 0 |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | Lectec Corp. | 1988-07-20 | 55 | 0 |
| K881872 | TENS ELECTRODE MODEL 238P | Lectec Corp. | 1988-06-16 | 44 | 0 |
| K881871 | SPARE MS 700 TENS ELECTRODE | Lectec Corp. | 1988-06-16 | 44 | 0 |
| K875015 | TRACETS 3000 | Lectec Corp. | 1988-01-28 | 55 | 0 |
| K872250 | LECTEC STIMULATING ELECTRODE | Lectec Corp. | 1987-08-07 | 56 | 0 |
| K872012 | LECTEC NON-INVASIVE PACING ELECTRODE | Lectec Corp. | 1987-06-29 | 34 | 0 |
| K870873 | MD MONITORING/DIAGNOSTIC ELECTRODE | Lectec Corp. | 1987-04-10 | 38 | 0 |
| K863674 | TRACETS 2000/ELECTRODES | Lectec Corp. | 1987-03-11 | 173 | 0 |
| K863194 | TENDERM TAPE | Lectec Corp. | 1986-09-30 | 42 | 0 |
| K862765 | EUROMED S-601 | Lectec Corp. | 1986-08-06 | 15 | 0 |
| K840445 | SYNKARA | Lectec Corp. | 1985-05-16 | 472 | 0 |
| K840446 | MEDICAL TAPE | Lectec Corp. | 1984-10-31 | 273 | 0 |
| K840609 | SKIN TECH. ISOTEX 86L | Lectec Corp. | 1984-10-31 | 261 | 0 |
| K840448 | MEDICAL ADHESIVE FOAM TAPE | Lectec Corp. | 1984-10-31 | 273 | 0 |
| K840447 | MICROPOROUS MED. ADHESIVE TAPE | Lectec Corp. | 1984-08-17 | 198 | 0 |
| K833590 | DRESS, SURGICAL ADHESIVE | Lectec Corp. | 1984-01-27 | 107 | 0 |
| K830798 | STERILE SURGICAL PAIN RELIEF ELECTRODE | Lectec Corp. | 1983-04-05 | 22 | 0 |
| K771719 | KARAYA ELECTRODES | Lectec Corp. | 1977-09-20 | 8 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda