510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915577Substantially Equivalent

Impraflo Postoperative Autotransfusion Device

Impra, Inc., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915577 is the FDA 510(k) clearance record for IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE, a class II device, cleared for Impra, Inc. on under FDA product code CAR (Monitor, Spinal-Fluid Pressure, Electrically Powered). FDA records list 24 510(k) clearances for Impra, Inc., from to . As of , FDA records show no recalls naming K915577.

Clearance record

Decision date
Received
(89 days to decision)
Product code
CAR Monitor, Spinal-Fluid Pressure, Electrically Powered
Regulation
21 CFR 880.2460
Device class
Class II
Review panel
General Hospital
Applicant
Impra, Inc. 1625 W. 3rd St., Tempe AZ
510(k) summary
Summary
Third party review
No

Clearances, product code CAR

Trailing 12 months

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

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