510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912045Substantially Equivalent

Tmp Pressure Isolatorr, Tmp Pressure Monitor Syst

Lifestream Int'L, Inc., The Woodlands TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912045 is the FDA 510(k) clearance record for TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST, a class II device, cleared for Lifestream Int'L, Inc. on under FDA product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass). FDA records list 23 510(k) clearances for Lifestream Int'L, Inc., from to . As of , FDA records show no recalls naming K912045.

Clearance record

Decision date
Received
(176 days to decision)
Product code
DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Regulation
21 CFR 870.4310
Device class
Class II
Review panel
Cardiovascular
Applicant
Lifestream Int'L, Inc. 2828 N.Crescent River Dr., The Woodlands TX
510(k) summary
Summary
Third party review
No

Clearances, product code DXS

Trailing 12 months

FDA records hold no clearances under product code DXS in the trailing twelve months.

FDA records show no clearances under product code DXS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260