Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & W Medico Teknik · Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
207 daysmedian FDA review time
609 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940933 | 9267 SPO2 ATHENA MODULE | S & W Medico Teknik | 1995-11-29 | 639 | 0 |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | S & W Medico Teknik | 1994-05-03 | 1030 | 0 |
| K915633 | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA | S & W Medico Teknik | 1993-06-29 | 609 | 0 |
| K930134 | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT | S & W Medico Teknik | 1993-04-09 | 87 | 0 |
| K923418 | 9293/1 INTERFACE MODULE | S & W Medico Teknik | 1993-02-23 | 225 | 0 |
| K911611 | SYSTEM ATHENA, MODIFICATION | S & W Medico Teknik | 1993-02-05 | 668 | 0 |
| K922314 | VENTILATOR INTERFACE 9291/4 | S & W Medico Teknik | 1992-12-17 | 213 | 0 |
| K912815 | NIBP 9225 COMBI | S & W Medico Teknik | 1992-10-09 | 491 | 0 |
| K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER | S & W Medico Teknik | 1992-09-21 | 516 | 0 |
| K912183 | TYPE 9050/NEO | S & W Medico Teknik | 1992-06-23 | 404 | 0 |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | S & W Medico Teknik | 1992-05-05 | 392 | 0 |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | 1992-04-10 | 297 | 0 |
| K912049 | SYSTEM ATHENA - PRODUCT ENHANCEMENTS | S & W Medico Teknik | 1991-12-05 | 240 | 0 |
| K903940 | TYPE 9210 S/ECG | S & W Medico Teknik | 1991-12-04 | 464 | 0 |
| K911761 | SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION | S & W Medico Teknik | 1991-10-31 | 223 | 0 |
| K905506 | ACCUCORE TELEMETRY, MODIFICATION | S & W Medico Teknik | 1991-09-06 | 281 | 0 |
| K911264 | CALIBRATION KIT | S & W Medico Teknik | 1991-08-02 | 144 | 0 |
| K900366 | ARRHYTHMIA 9215 | S & W Medico Teknik | 1991-04-26 | 455 | 0 |
| K902779 | MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA | S & W Medico Teknik | 1990-09-27 | 113 | 0 |
| K896738 | TYPE 9293 INTERFACE PULSEOX | S & W Medico Teknik | 1990-08-14 | 257 | 0 |
| K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) | S & W Medico Teknik | 1990-07-17 | 655 | 0 |
| K896700 | TYPE 9140/NEO | S & W Medico Teknik | 1990-04-20 | 143 | 0 |
| K896699 | TYPE 9040/NEO | S & W Medico Teknik | 1990-04-20 | 143 | 0 |
| K896736 | TYPE 9291 INTERFACE RESPIRATOR | S & W Medico Teknik | 1990-02-28 | 90 | 0 |
| K896737 | TYPE 9292 INTERFACE CAPNOGRAPH | S & W Medico Teknik | 1990-02-28 | 90 | 0 |
| K896735 | TYPE 9290 INTERFACE RESPIRATOR | S & W Medico Teknik | 1990-02-28 | 90 | 0 |
| K895001 | TYPE EXPIRED CO2 9270, CAPNOGRAPH | S & W Medico Teknik | 1990-02-22 | 203 | 0 |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | S & W Medico Teknik | 1990-01-26 | 176 | 0 |
| K894920 | SELECTRODE | S & W Medico Teknik | 1989-10-03 | 62 | 0 |
| K894699 | TYPE 9140 (SYSTEM ATHENA) | S & W Medico Teknik | 1989-10-02 | 70 | 0 |
| K894700 | TYPE PDU/CDU 9040 (SYSTEM ATHENA) | S & W Medico Teknik | 1989-10-02 | 70 | 0 |
| K890005 | TYPE 9225 NIBP | S & W Medico Teknik | 1989-05-11 | 128 | 0 |
| K884980 | F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM | S & W Medico Teknik | 1989-05-01 | 153 | 0 |
| K884116 | TYPE 9040 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-26 | 208 | 0 |
| K884117 | TYPE 9210 ECG SYSTEM ATHENA | S & W Medico Teknik | 1989-04-26 | 208 | 0 |
| K884122 | TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | 207 | 0 |
| K884121 | TYPE 9266 SAO2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | 207 | 0 |
| K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | 207 | 0 |
| K884981 | F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM | S & W Medico Teknik | 1989-03-10 | 101 | 0 |
| K884982 | M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 | S & W Medico Teknik | 1989-03-10 | 101 | 0 |
| K884983 | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 | S & W Medico Teknik | 1989-03-09 | 100 | 0 |
| K884984 | M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 | S & W Medico Teknik | 1989-03-09 | 100 | 0 |
| K884119 | TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA | S & W Medico Teknik | 1988-11-02 | 33 | 0 |
| K864586 | S&W ELECTRODE TYPES 888, 844, 988 AND 944 | S & W Medico Teknik | 1987-03-13 | 112 | 0 |
| K851931 | DEFI 2 | S & W Medico Teknik | 1985-08-05 | 95 | 0 |
| K833689 | DIASCOPE 2 | S & W Medico Teknik | 1984-10-26 | 374 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda