510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231335Substantially Equivalent

Cleerly ISCHEMIA

Cleerly, Inc, Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231335 is the FDA 510(k) clearance record for Cleerly ISCHEMIA, a class II device, cleared for Cleerly, Inc. on under FDA product code QXZ (Adjunctive Epicardial Vascular Physiologic Status Indicator). FDA's definition for product code QXZ reads: "The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally...". FDA records list 6 510(k) clearances for Cleerly, Inc., from to . As of , FDA records show no recalls naming K231335.

Clearance record

Decision date
Received
(123 days to decision)
Product code
QXZ Adjunctive Epicardial Vascular Physiologic Status Indicator
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Applicant
Cleerly, Inc. 110 16th Steet Suite 1400 #104, Denver CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXZ

Trailing 12 months

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

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