Labeltape Meditect, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Labeltape Meditect, Inc.” (first 1986, latest 1995), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 | 10 | 10 |
| GXY | Electrode, Cutaneous | 9 | 9 |
| KHE | Reagent, Occult Blood | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (12)
- Neurology (10)
- Hematology (2)
- General and Plastic Surgery (1)
Most recent Labeltape Meditect, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD | GEI | 1995-04-25 | 33 |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | GXY | 1992-01-14 | 49 |
| K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL | GZJ | 1991-12-18 | 50 |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | KHE | 1991-10-04 | 123 |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | DRX | 1990-09-04 | 75 |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | GXY | 1990-07-19 | 29 |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | GXY | 1990-03-01 | 20 |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | GXY | 1990-02-12 | 69 |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | GXY | 1990-01-22 | 40 |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | DRX | 1989-10-26 | 79 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Labeltape Meditect, 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 Labeltape Meditect, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Labeltape Meditect, Inc.” (first 1986, latest 1995), across 8 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 Labeltape Meditect, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Labeltape Meditect, Inc. is 64 days.
Which FDA product codes appear under Labeltape Meditect, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 10); GXY (Electrode, Cutaneous, 9); KHE (Reagent, Occult Blood, 2).
Next steps
- See all 26 Labeltape Meditect, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Labeltape Meditect, 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 (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.