510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180021Unknown

Early Bird Bleed Monitoring System

Saranas, Inc., Houston TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN180021 is the FDA 510(k) clearance record for Early Bird Bleed Monitoring System, a class II device, cleared for Saranas, Inc. on under FDA product code QFJ (Intravascular Bleed Monitor). FDA's definition for product code QFJ reads: "An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications". FDA records list 2 510(k) clearances for Saranas, Inc., from to . As of , FDA records show no recalls naming DEN180021.

Clearance record

Decision date
Received
(312 days to decision)
Product code
QFJ Intravascular Bleed Monitor
Regulation
21 CFR 870.1345
Device class
Class II
Review panel
Cardiovascular
Applicant
Saranas, Inc. 2450 Holcombe Blvd., Suite X, Houston TX
Third party review
No

Clearances, product code QFJ

Trailing 12 months

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

FDA records show no clearances under product code QFJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFJ, 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