510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K241868Substantially Equivalent

xR IVD

TEMPUS AI, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241868 is the FDA 510(k) clearance record for xR IVD, a class II device, cleared for Tempus AI, Inc. on under FDA product code PZM (Next Generation Sequencing Based Tumor Profiling Test). FDA's definition for product code PZM reads: "A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens...". FDA records list 3 510(k) clearances for Tempus AI, Inc., from to . As of , FDA records show no recalls naming K241868.

Clearance record

Decision date
Received
(449 days to decision)
Product code
PZM Next Generation Sequencing Based Tumor Profiling Test
Regulation
21 CFR 866.6080
Device class
Class II
Review panel
Pathology
Applicant
Tempus AI, Inc. 600 W Chicago Ave., Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZM

Trailing 12 months
1 clearance under product code PZM in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260