Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Labeltape Meditect, Inc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
123 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSI | Labeltape Meditect, Inc. | 1995-04-25 | 33 | 0 |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | Labeltape Meditect, Inc. | 1992-01-14 | 49 | 1 |
| K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL | Labeltape Meditect, Inc. | 1991-12-18 | 50 | 0 |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | Labeltape Meditect, Inc. | 1991-10-04 | 123 | 0 |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | Labeltape Meditect, Inc. | 1990-09-04 | 75 | 0 |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | Labeltape Meditect, Inc. | 1990-07-19 | 29 | 0 |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | Labeltape Meditect, Inc. | 1990-03-01 | 20 | 0 |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | Labeltape Meditect, Inc. | 1990-02-12 | 69 | 0 |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | Labeltape Meditect, Inc. | 1990-01-22 | 40 | 0 |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | Labeltape Meditect, Inc. | 1989-10-26 | 79 | 0 |
| K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER | Labeltape Meditect, Inc. | 1989-10-12 | 86 | 0 |
| K894042 | SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS | Labeltape Meditect, Inc. | 1989-08-11 | 66 | 0 |
| K894043 | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS | Labeltape Meditect, Inc. | 1989-08-11 | 66 | 0 |
| K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST | Labeltape Meditect, Inc. | 1989-04-18 | 194 | 0 |
| K880649 | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING | Labeltape Meditect, Inc. | 1988-03-04 | 16 | 0 |
| K872866 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) | Labeltape Meditect, Inc. | 1988-01-28 | 191 | 0 |
| K875041 | FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE | Labeltape Meditect, Inc. | 1988-01-28 | 56 | 0 |
| K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) | Labeltape Meditect, Inc. | 1987-12-30 | 63 | 0 |
| K874628 | RESUBMITTED STANDARD MICROPORE ECG ELECTRODE | Labeltape Meditect, Inc. | 1987-12-07 | 46 | 0 |
| K872869 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) | Labeltape Meditect, Inc. | 1987-11-04 | 106 | 0 |
| K872871 | NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) | Labeltape Meditect, Inc. | 1987-10-16 | 87 | 0 |
| K871026 | DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS | Labeltape Meditect, Inc. | 1987-04-22 | 37 | 0 |
| K865011 | PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER | Labeltape Meditect, Inc. | 1987-03-13 | 80 | 0 |
| K865090 | PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE | Labeltape Meditect, Inc. | 1987-02-19 | 51 | 0 |
| K863366 | PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE | Labeltape Meditect, Inc. | 1986-11-21 | 79 | 0 |
| K862756 | PREGELLED INFANT DISPOSABLE ECG ELECTRODE | Labeltape Meditect, Inc. | 1986-08-06 | 15 | 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