Medicotest, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medicotest, Inc.” (first 1982, latest 1999), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 87 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 | 5 | 5 |
| GXY | Electrode, Cutaneous | 5 | 5 |
| GXZ | Electrode, Needle | 2 | 2 |
| GYB | Media, Electroconductive | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Review panels
Most recent Medicotest, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | GXZ | 1999-01-11 | 90 |
| K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | GXY | 1997-05-15 | 84 |
| K961643 | MEDICOTEST ECG ELECTRODES | DRX | 1996-12-09 | 224 |
| K952176 | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K | GXY | 1995-09-25 | 140 |
| K941568 | K-10-VS, DA-05-VS, RECORDING ELECTRODES | GXY | 1994-11-04 | 218 |
| K931430 | CUTANEOUS ELECTRODE | GXY | 1993-12-21 | 274 |
| K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | GXY | 1993-12-21 | 274 |
| K926264 | MEDICOTEST SKIN FIX | KGX | 1993-04-20 | 123 |
| K921579 | BR-50-J DISPOSABLE ECG ELECTRODE | DRX | 1992-05-26 | 54 |
| K914672 | QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE | DRX | 1991-10-31 | 13 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicotest, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medicotest A/S (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicotest, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Medicotest, Inc.” (first 1982, latest 1999), across 5 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 Medicotest, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicotest, Inc. is 87 days.
Which FDA product codes appear under Medicotest, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 5); GXY (Electrode, Cutaneous, 5); GXZ (Electrode, Needle, 2).
Next steps
- See all 14 Medicotest, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Medicotest, 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.