Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life-Tech Intl., Inc. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
413 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | Life-Tech Intl., Inc. | 2000-07-06 | 90 | 1 |
| K955031 | MAXISTIM | Life-Tech Intl., Inc. | 1996-12-10 | 404 | 0 |
| K954505 | EZ STIM | Life-Tech Intl., Inc. | 1996-12-10 | 439 | 0 |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Life-Tech Intl., Inc. | 1995-11-30 | 76 | 0 |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Life-Tech Intl., Inc. | 1995-10-17 | 29 | 0 |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Life-Tech Intl., Inc. | 1995-10-05 | 79 | 0 |
| K953353 | UROVISION JANUS | Life-Tech Intl., Inc. | 1995-09-08 | 53 | 0 |
| K946108 | EAR-A-GATOR | Life-Tech Intl., Inc. | 1995-06-13 | 181 | 0 |
| K913601 | MICROPHOR | Life-Tech Intl., Inc. | 1994-07-15 | 1067 | 0 |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Life-Tech Intl., Inc. | 1994-03-30 | 76 | 0 |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | 1993-11-18 | 254 | 0 |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 | 189 | 0 |
| K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE | Life-Tech Intl., Inc. | 1993-09-07 | 413 | 0 |
| K923634 | MODIFIED F-10 CULTURE MEDIUM | Life-Tech Intl., Inc. | 1993-09-07 | 413 | 0 |
| K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Life-Tech Intl., Inc. | 1993-09-07 | 413 | 0 |
| K923651 | DISTILLED WATER | Life-Tech Intl., Inc. | 1993-09-07 | 413 | 0 |
| K926349 | PROBLOC INSULATED NEEDLES | Life-Tech Intl., Inc. | 1993-07-29 | 224 | 0 |
| K923072 | HANDTYMP | Life-Tech Intl., Inc. | 1993-03-18 | 266 | 0 |
| K923073 | AUTOMATIC TYMPANOMETER | Life-Tech Intl., Inc. | 1993-02-19 | 239 | 0 |
| K923071 | DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT | Life-Tech Intl., Inc. | 1992-09-28 | 95 | 0 |
| K923074 | DANPLEX SCREENING AUDIOMETER | Life-Tech Intl., Inc. | 1992-09-23 | 90 | 0 |
| K904385 | JANUS ATAC ENG ANALYSIS SYSTEM | Life-Tech Intl., Inc. | 1992-06-10 | 625 | 0 |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | 1992-02-24 | 80 | 0 |
| K913184 | MS-III MINISTIM | Life-Tech Intl., Inc. | 1991-10-07 | 81 | 0 |
| K904557 | MICROFLO | Life-Tech Intl., Inc. | 1990-12-28 | 84 | 0 |
| K904386 | UROLAB JANUS | Life-Tech Intl., Inc. | 1990-11-27 | 64 | 0 |
| K903494 | MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP | Life-Tech Intl., Inc. | 1990-10-17 | 75 | 0 |
| K903495 | LIQUID DETECTOR | Life-Tech Intl., Inc. | 1990-10-05 | 63 | 0 |
| K902120 | MERCURY RHINOMANOMETER | Life-Tech Intl., Inc. | 1990-08-06 | 87 | 0 |
| K896784 | DISPOSABLE URODYNAMIC CATHETER SET | Life-Tech Intl., Inc. | 1990-02-16 | 74 | 0 |
| K882585 | CAVROLAB | Life-Tech Intl., Inc. | 1989-03-02 | 253 | 0 |
| K882554 | MEDITRODE KIT | Life-Tech Intl., Inc. | 1988-12-23 | 185 | 0 |
| K881842 | TRACER | Life-Tech Intl., Inc. | 1988-08-31 | 121 | 0 |
| K874307 | MODEL DMC-75 MINI-CATHETER SET | Life-Tech Intl., Inc. | 1988-01-29 | 101 | 0 |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | 1988-01-27 | 135 | 0 |
| K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | Life-Tech Intl., Inc. | 1987-11-13 | 170 | 0 |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Life-Tech Intl., Inc. | 1987-10-28 | 251 | 0 |
| K871129 | CAVROPUMP | Life-Tech Intl., Inc. | 1987-08-28 | 161 | 0 |
| K873109 | MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET | Life-Tech Intl., Inc. | 1987-08-28 | 21 | 0 |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | 1987-08-27 | 90 | 0 |
| K871869 | MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. | Life-Tech Intl., Inc. | 1987-08-11 | 90 | 0 |
| K870272 | MODEL 6110C OTOPHOR | Life-Tech Intl., Inc. | 1987-08-05 | 190 | 0 |
| K870118 | MODEL 6110B DENTAPHOR | Life-Tech Intl., Inc. | 1987-04-10 | 88 | 0 |
| K870338 | MODEL MS-II MINISTIM | Life-Tech Intl., Inc. | 1987-03-11 | 42 | 0 |
| K863166 | MODEL 6110 IONTOPHORETIC APPLICATOR | Life-Tech Intl., Inc. | 1987-03-04 | 198 | 0 |
| K863165 | MODEL 4-SC FOUR WAY STOPCOCK | Life-Tech Intl., Inc. | 1986-10-28 | 71 | 0 |
| K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR | Life-Tech Intl., Inc. | 1986-10-24 | 67 | 0 |
| K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD | Life-Tech Intl., Inc. | 1986-10-24 | 67 | 0 |
| K863169 | MODEL AS-72 ADMINISTRATION SET | Life-Tech Intl., Inc. | 1986-09-09 | 22 | 0 |
| K862327 | MODEL RCV REFLUX CHECK VALVE | Life-Tech Intl., Inc. | 1986-09-04 | 77 | 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