S & W Medico Teknik: FDA clearances and approvals
S & W Medico Teknik has 46 FDA 510(k) clearances (first 1984, latest 1995), across 18 product codes in 3 review panels. Median 510(k) review time: 207 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 8 | 8 |
| DRX | Electrode, Electrocardiograph | 7 | 7 |
| DQA | Oximeter | 6 | 6 |
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| DPS | Electrocardiograph | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DSK | Computer, Blood-Pressure | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
Plus 8 more product codes.
Review panels
- Cardiovascular (28)
- Anesthesiology (15)
- General Hospital (3)
Most recent S & W Medico Teknik 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940933 | 9267 SPO2 ATHENA MODULE | DQA | 1995-11-29 | 639 |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | LKD | 1994-05-03 | 1030 |
| K915633 | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA | FLL | 1993-06-29 | 609 |
| K930134 | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT | DPS | 1993-04-09 | 87 |
| K923418 | 9293/1 INTERFACE MODULE | DQA | 1993-02-23 | 225 |
| K911611 | SYSTEM ATHENA, MODIFICATION | DRT | 1993-02-05 | 668 |
| K922314 | VENTILATOR INTERFACE 9291/4 | CBK | 1992-12-17 | 213 |
| K912815 | NIBP 9225 COMBI | DXN | 1992-10-09 | 491 |
| K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER | FMZ | 1992-09-21 | 516 |
| K912183 | TYPE 9050/NEO | DPS | 1992-06-23 | 404 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named S & W Medico Teknik.
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 S & W Medico Teknik have?
S & W Medico Teknik has 46 FDA 510(k) clearances (first 1984, latest 1995), across 18 product codes in 3 review panels.
How long does FDA take to clear S & W Medico Teknik's 510(k)s?
The median time from FDA receipt to decision across S & W Medico Teknik's cleared 510(k)s is 207 days.
What devices does S & W Medico Teknik make?
Its most frequent FDA product codes are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 8); DRX (Electrode, Electrocardiograph, 7); DQA (Oximeter, 6).
Has S & W Medico Teknik had device recalls?
openFDA lists no recalls under a recalling firm name matching S & W Medico Teknik. Related entities may recall under other names.
Next steps
- See all 46 S & W Medico Teknik clearances with predicates and recalls
- Run predicate analysis for product code DRT, S & W Medico Teknik'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.