Life-Tech Instruments, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Life-Tech Instruments, Inc.” (first 1977, latest 1981), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 2 | 2 |
| EWO | Audiometer | 1 | 1 |
| EXQ | Cystometer, Electrical Recording | 1 | 1 |
| EXY | Uroflowmeter | 1 | 1 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
Plus 6 more product codes.
Review panels
- Neurology (11)
- Gastroenterology and Urology (5)
- Ophthalmic (2)
- Ear, Nose and Throat (1)
Most recent Life-Tech Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | EXQ | 1981-09-09 | 37 |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | HCC | 1981-08-25 | 22 |
| K812180 | LIFE-TECH #5102 VISULAB | GWN | 1981-08-21 | 18 |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | FAP | 1981-08-13 | 10 |
| K800112 | AMBLYOPIA TRAINER | HPL | 1980-03-10 | 54 |
| K790663 | MODEL 1750 STANDING URINAL | FFG | 1979-04-24 | 18 |
| K790664 | MODEL 1309 AUDIO MONITOR | IKN | 1979-04-23 | 17 |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | HLZ | 1978-11-15 | 79 |
| K781461 | MODEL 7320 VISUAL STIMULATOR | GWE | 1978-11-08 | 82 |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | GYA | 1978-09-07 | 10 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life-Tech Instruments, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Life-Tech Intl., Inc. (68 510(k)s)
- Life-Tech, Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life-Tech Instruments, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Life-Tech Instruments, Inc.” (first 1977, latest 1981), across 16 product codes in 4 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 Life-Tech Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life-Tech Instruments, Inc. is 18 days.
Which FDA product codes appear under Life-Tech Instruments, Inc.?
The most frequent FDA product codes under this applicant name are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 2); GWJ (Stimulator, Auditory, Evoked Response, 2); IKN (Electromyograph, Diagnostic, 2).
Next steps
- See all 19 Life-Tech Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Life-Tech Instruments, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.