Zymed Medical Instrumentation: FDA clearances and approvals
Zymed Medical Instrumentation has 7 FDA 510(k) clearances (first 1993, latest 2000), across 5 product codes in 1 review panel. Median 510(k) review time: 92 days.
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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Zymed Medical Instrumentation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002004 | ZYBIT | DXH | 2000-09-21 | 80 |
| K992197 | MODIFICATION TO ZYMED HOLTER 2000 | MLO | 1999-07-28 | 28 |
| K990170 | HOLTER 2000 | MLO | 1999-04-13 | 84 |
| K984089 | ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW | DSI | 1999-02-16 | 92 |
| K955015 | ZYMED HOLTER SCANNER MODEL 2010 | DQK | 1996-03-18 | 138 |
| K951370 | ZYMED TELEMETRY SYSTEM; MODEL T8010 | DSI | 1995-10-06 | 193 |
| K930894 | MULTITRAK-PLUS | DSH | 1993-11-01 | 252 |
Recalls
openFDA lists no recalls under a recalling firm named Zymed Medical Instrumentation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Zymed Medical Instrumentation have?
Zymed Medical Instrumentation has 7 FDA 510(k) clearances (first 1993, latest 2000), across 5 product codes in 1 review panel.
How long does FDA take to clear Zymed Medical Instrumentation's 510(k)s?
The median time from FDA receipt to decision across Zymed Medical Instrumentation's cleared 510(k)s is 92 days.
What devices does Zymed Medical Instrumentation make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 2); MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm, 2); DQK (Computer, Diagnostic, Programmable, 1).
Has Zymed Medical Instrumentation had device recalls?
openFDA lists no recalls under a recalling firm name matching Zymed Medical Instrumentation. Related entities may recall under other names.
Next steps
- See all 7 Zymed Medical Instrumentation clearances with predicates and recalls
- Run predicate analysis for product code DSI, Zymed Medical Instrumentation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.