Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiotronics, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
196 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932903 | EKG VEST | Cardiotronics, Inc. | 1995-02-24 | 618 | 0 |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | Cardiotronics, Inc. | 1992-12-01 | 211 | 0 |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Cardiotronics, Inc. | 1992-09-18 | 74 | 0 |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | Cardiotronics, Inc. | 1992-06-11 | 30 | 0 |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | Cardiotronics, Inc. | 1992-06-11 | 34 | 0 |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | Cardiotronics, Inc. | 1992-06-11 | 34 | 0 |
| K921606 | MODEL #125 CHILD STIMULATION PADS | Cardiotronics, Inc. | 1992-05-26 | 53 | 0 |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | Cardiotronics, Inc. | 1992-02-03 | 26 | 0 |
| K914725 | COORDINATOR, CABLE INPUT | Cardiotronics, Inc. | 1991-11-05 | 15 | 0 |
| K912621 | MODEL #911 STEALTH MULTI PADS | Cardiotronics, Inc. | 1991-10-16 | 125 | 0 |
| K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS | Cardiotronics, Inc. | 1991-10-16 | 196 | 0 |
| K911455 | MODEL #100 SHOCK-TRODE CHILD DEFIB PADS | Cardiotronics, Inc. | 1991-10-16 | 196 | 0 |
| K911402 | MODEL #350 SHOCK-PLATE DEFIB ADAPTOR | Cardiotronics, Inc. | 1991-10-03 | 188 | 0 |
| K913226 | MODEL #810 STEALTH-STIM ADULT STIMULATION PADS | Cardiotronics, Inc. | 1991-09-04 | 47 | 0 |
| K910661 | MODEL 205 SHOCK-TRODE | Cardiotronics, Inc. | 1991-05-02 | 78 | 0 |
| K904466 | MODEL #250 DEFIB CABLE | Cardiotronics, Inc. | 1991-01-30 | 121 | 0 |
| K904462 | MODEL #210 STEALTH DEFIB PADS | Cardiotronics, Inc. | 1990-12-03 | 63 | 0 |
| K895113 | COORDINATOR | Cardiotronics, Inc. | 1989-10-26 | 72 | 0 |
| K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT | Cardiotronics, Inc. | 1988-11-18 | 21 | 0 |
| K884530 | TRIAD-EP II, PLATE INPUT | Cardiotronics, Inc. | 1988-11-17 | 20 | 0 |
| K883178 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE | Cardiotronics, Inc. | 1988-11-09 | 105 | 0 |
| K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY | Cardiotronics, Inc. | 1988-11-09 | 98 | 0 |
| K883523 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE | Cardiotronics, Inc. | 1988-10-06 | 50 | 0 |
| K882338 | MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE | Cardiotronics, Inc. | 1988-08-30 | 85 | 0 |
| K883375 | MODEL #918 MULTI-PADS | Cardiotronics, Inc. | 1988-08-30 | 21 | 0 |
| K882337 | MODEL #825 ADULT STIM. PADS POLYMER TYPE | Cardiotronics, Inc. | 1988-08-02 | 57 | 0 |
| K880936 | TRIAD-EP | Cardiotronics, Inc. | 1988-07-18 | 133 | 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