510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822812Substantially Equivalent

Ysi Model 23L Lactate Analyzer

Yellow Springs Instrument Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822812 is the FDA 510(k) clearance record for YSI MODEL 23L LACTATE ANALYZER, a class II device, cleared for Yellow Springs Instrument Co., Inc. on under FDA product code HHP (Table, Obstetrical, Manual (And Accessories)). FDA records list 23 510(k) clearances for Yellow Springs Instrument Co., Inc., from to . As of , FDA records show no recalls naming K822812.

Clearance record

Decision date
Received
(84 days to decision)
Product code
HHP Table, Obstetrical, Manual (And Accessories)
Regulation
21 CFR 884.4900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Yellow Springs Instrument Co., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HHP

Trailing 12 months

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

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