Life-Tech, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Life-Tech, Inc.” (first 2005, latest 2012), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 120 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 | 1 | 85 |
| 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 5 | 5 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
Most recent Life-Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120234 | EZONO 3000 | IYN | 2012-04-19 | 85 |
| K111355 | ECHOBRIGHT | CAZ | 2011-09-16 | 123 |
| K102813 | EZONO 3000 | IYN | 2011-06-30 | 275 |
| K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | 2010-12-22 | 159 |
| K093662 | ECHOBRIGHT | CAZ | 2010-06-24 | 211 |
| K093485 | VESISCAN | IYO | 2010-03-16 | 127 |
| K082772 | STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 | BSP | 2009-02-09 | 140 |
| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | FFX | 2008-11-07 | 109 |
| K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | CAC | 2008-10-24 | 23 |
| K081864 | PROLONG | BSP | 2008-09-25 | 86 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life-Tech, 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 Instruments, Inc. (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life-Tech, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Life-Tech, Inc.” (first 2005, latest 2012), across 7 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life-Tech, Inc. is 120 days.
Which FDA product codes appear under Life-Tech, Inc.?
The most frequent FDA product codes under this applicant name are CAZ (Anesthesia Conduction Kit, 5); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Next steps
- See all 14 Life-Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Life-Tech, 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.