S & W Medico Teknik: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “S & W Medico Teknik” (first 1984, latest 1995), across 18 product codes in 3 review panels. Median 510(k) review time under this name: 207 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 |
|---|---|---|---|
| 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 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 S & W Medico Teknik?
FDA lists 46 510(k) clearances under the applicant name “S & W Medico Teknik” (first 1984, latest 1995), across 18 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 S & W Medico Teknik?
The median time from FDA receipt to decision across 510(k)s cleared under the name S & W Medico Teknik is 207 days.
Which FDA product codes appear under S & W Medico Teknik?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 8); DRX (Electrode, Electrocardiograph, 7); DQA (Oximeter, 6).
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. 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.