Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life-Tech Instruments, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
80 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | 1981-09-09 | 37 | 0 |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | Life-Tech Instruments, Inc. | 1981-08-25 | 22 | 0 |
| K812180 | LIFE-TECH #5102 VISULAB | Life-Tech Instruments, Inc. | 1981-08-21 | 18 | 0 |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Life-Tech Instruments, Inc. | 1981-08-13 | 10 | 0 |
| K800112 | AMBLYOPIA TRAINER | Life-Tech Instruments, Inc. | 1980-03-10 | 54 | 0 |
| K790663 | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | 1979-04-24 | 18 | 0 |
| K790664 | MODEL 1309 AUDIO MONITOR | Life-Tech Instruments, Inc. | 1979-04-23 | 17 | 0 |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | 1978-11-15 | 79 | 0 |
| K781461 | MODEL 7320 VISUAL STIMULATOR | Life-Tech Instruments, Inc. | 1978-11-08 | 82 | 0 |
| K781474 | PREAMPLIFIER MODELS 8101PI & 8102PI | Life-Tech Instruments, Inc. | 1978-09-07 | 10 | 0 |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Life-Tech Instruments, Inc. | 1978-09-07 | 10 | 0 |
| K780539 | STIMULATOR MODEL 8021 | Life-Tech Instruments, Inc. | 1978-06-22 | 80 | 0 |
| K780537 | EAR ELECTRODE-ADULT & PEDIATRIC | Life-Tech Instruments, Inc. | 1978-06-02 | 60 | 0 |
| K780541 | PRESSURE MODULES MODELS 1855 & 1856 | Life-Tech Instruments, Inc. | 1978-05-19 | 46 | 0 |
| K780540 | ELECTRIC RESPONSE AUDIOMETER | Life-Tech Instruments, Inc. | 1978-04-21 | 18 | 0 |
| K780538 | AUDIO MONITOR-MODEL 8309 | Life-Tech Instruments, Inc. | 1978-04-19 | 16 | 0 |
| K770897 | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | 1977-06-03 | 18 | 0 |
| K770579 | CATHETER, URETHRAL PRESSURE, UPE-10 & 12 | Life-Tech Instruments, Inc. | 1977-05-23 | 56 | 0 |
| K770268 | SYS. FOR REC. BSER RESPONSES | Life-Tech Instruments, Inc. | 1977-02-28 | 17 | 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