510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153165Substantially Equivalent

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

Astute Medical, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153165 is the FDA 510(k) clearance record for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit, a class II device, cleared for Astute Medical, Inc. on under FDA product code PIG (Acute Kidney Injury Test System). FDA's definition for product code PIG reads: "An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with...". FDA records list 3 510(k) clearances for Astute Medical, Inc., from to . As of , FDA records show no recalls naming K153165.

Clearance record

Decision date
Received
(212 days to decision)
Product code
PIG Acute Kidney Injury Test System
Regulation
21 CFR 862.1220
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Astute Medical, Inc. 3550 General Atomics Ct.,, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIG

Trailing 12 months

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

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