Lifestream Int'L, Inc.: FDA clearances and approvals
Lifestream Int'L, Inc. has 23 FDA 510(k) clearances (first 1984, latest 1997), across 14 product codes in 4 review panels. Median 510(k) review time: 71 days.
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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 7 | 7 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 | 1 |
| FTX | Mirror, General & Plastic Surgery | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (11)
- Cardiovascular (6)
- General Hospital (2)
- Orthopedic (1)
Most recent Lifestream Int'L, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | DTR | 1997-08-08 | 267 |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | GEX | 1996-09-11 | 85 |
| K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER | DTN | 1993-05-13 | 485 |
| K920618 | AUTOTRANSFUSION SUCTION SET | CAC | 1993-03-12 | 395 |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | CAC | 1992-05-20 | 307 |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | GEX | 1991-12-23 | 83 |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | DXS | 1991-10-31 | 176 |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | GEX | 1991-04-22 | 18 |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | GEX | 1991-03-29 | 37 |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | DQO | 1991-02-01 | 122 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lifestream Int'L, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lifestream Int'L, Inc. have?
Lifestream Int'L, Inc. has 23 FDA 510(k) clearances (first 1984, latest 1997), across 14 product codes in 4 review panels.
How long does FDA take to clear Lifestream Int'L, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lifestream Int'L, Inc.'s cleared 510(k)s is 71 days.
What devices does Lifestream Int'L, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 7); CAC (Apparatus, Autotransfusion, 2); DQO (Catheter, Intravascular, Diagnostic, 1).
Has Lifestream Int'L, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lifestream Int'L, Inc. Related entities may recall under other names.
Next steps
- See all 23 Lifestream Int'L, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lifestream Int'L, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.