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
K071231Substantially Equivalent

Edac Quantifier

Luna Innovations, Inc., Blacksburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071231 is the FDA 510(k) clearance record for EDAC QUANTIFIER, a class II device, cleared for Luna Innovations, Inc. on under FDA product code KRL (Detector, Bubble, Cardiopulmonary Bypass). FDA records list one 510(k) clearance for Luna Innovations, Inc. As of , FDA records show no recalls naming K071231.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KRL Detector, Bubble, Cardiopulmonary Bypass
Regulation
21 CFR 870.4205
Device class
Class II
Review panel
Cardiovascular
Applicant
Luna Innovations, Inc. 3157 State St., Blacksburg VA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KRL

Trailing 12 months

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

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