Life-Tech Intl., Inc.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Life-Tech Intl., Inc.” (first 1982, latest 2000), across 32 product codes in 10 review panels. Median 510(k) review time under this name: 88 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 | 14 | 14 |
| FEN | Device, Cystometric, Hydraulic | 5 | 5 |
| EGJ | Device, Iontophoresis, Other Uses | 4 | 4 |
| HLX | Photostimulator, Ac-Powered | 4 | 4 |
| MFD | Cannula, Intrauterine Insemination | 4 | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 3 | 3 |
| DXT | Injector And Syringe, Angiographic | 3 | 3 |
| EXY | Uroflowmeter | 3 | 3 |
| EAT | Tester, Pulp | 2 | 2 |
| ETY | Tester, Auditory Impedance | 2 | 2 |
Plus 22 more product codes.
Review panels
- Gastroenterology and Urology (28)
- Anesthesiology (8)
- Ear, Nose and Throat (7)
- Ophthalmic (6)
- General Hospital (5)
- Obstetrics and Gynecology (4)
- Physical Medicine (4)
- Dental (2)
- Neurology (2)
- Radiology (1)
Most recent Life-Tech Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | CAZ | 2000-07-06 | 90 |
| K955031 | MAXISTIM | KOI | 1996-12-10 | 404 |
| K954505 | EZ STIM | KOI | 1996-12-10 | 439 |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | FEN | 1995-11-30 | 76 |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | FEN | 1995-10-17 | 29 |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | FEN | 1995-10-05 | 79 |
| K953353 | UROVISION JANUS | FEN | 1995-09-08 | 53 |
| K946108 | EAR-A-GATOR | KHH | 1995-06-13 | 181 |
| K913601 | MICROPHOR | EGJ | 1994-07-15 | 1067 |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | FEN | 1994-03-30 | 76 |
58 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life-Tech Intl., 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 Instruments, Inc. (19 510(k)s)
- Life-Tech, Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life-Tech Intl., Inc.?
FDA lists 68 510(k) clearances under the applicant name “Life-Tech Intl., Inc.” (first 1982, latest 2000), across 32 product codes in 10 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 Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life-Tech Intl., Inc. is 88 days.
Which FDA product codes appear under Life-Tech Intl., Inc.?
The most frequent FDA product codes under this applicant name are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 14); FEN (Device, Cystometric, Hydraulic, 5); EGJ (Device, Iontophoresis, Other Uses, 4).
Next steps
- See all 68 Life-Tech Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Life-Tech Intl., 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.