Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifestream Int'L, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
307 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | Lifestream Int'L, Inc. | 1997-08-08 | 267 | 0 |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | Lifestream Int'L, Inc. | 1996-09-11 | 85 | 0 |
| K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER | Lifestream Int'L, Inc. | 1993-05-13 | 485 | 0 |
| K920618 | AUTOTRANSFUSION SUCTION SET | Lifestream Int'L, Inc. | 1993-03-12 | 395 | 0 |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | Lifestream Int'L, Inc. | 1992-05-20 | 307 | 0 |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | Lifestream Int'L, Inc. | 1991-12-23 | 83 | 0 |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Lifestream Int'L, Inc. | 1991-10-31 | 176 | 0 |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | Lifestream Int'L, Inc. | 1991-04-22 | 18 | 0 |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | Lifestream Int'L, Inc. | 1991-03-29 | 37 | 0 |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | Lifestream Int'L, Inc. | 1991-02-01 | 122 | 0 |
| K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH | Lifestream Int'L, Inc. | 1990-10-26 | 71 | 0 |
| K891909 | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS | Lifestream Int'L, Inc. | 1989-05-26 | 60 | 0 |
| K891130 | LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC | Lifestream Int'L, Inc. | 1989-05-23 | 81 | 0 |
| K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER | Lifestream Int'L, Inc. | 1987-05-28 | 71 | 0 |
| K870790 | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 | Lifestream Int'L, Inc. | 1987-04-01 | 34 | 0 |
| K862815 | LASER SURGICAL ROD | Lifestream Int'L, Inc. | 1986-11-17 | 116 | 0 |
| K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 | Lifestream Int'L, Inc. | 1986-10-14 | 62 | 0 |
| K863241 | LASER ASSISTED SURGICAL LAPAROSCOPY KITS | Lifestream Int'L, Inc. | 1986-09-12 | 21 | 0 |
| K863293 | DISPOSABLE SUCTION CANNULA NO. 902008-000 | Lifestream Int'L, Inc. | 1986-09-09 | 15 | 0 |
| K862213 | PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010 | Lifestream Int'L, Inc. | 1986-08-21 | 72 | 0 |
| K862954 | LASER PLUME FILTERS | Lifestream Int'L, Inc. | 1986-08-14 | 9 | 0 |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | 1986-07-23 | 22 | 0 |
| K843890 | CUSTOM INSTRUMENT DRAPE | Lifestream Int'L, Inc. | 1984-10-26 | 24 | 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