510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823766Substantially Equivalent

Blood Gas Incubator #260650

Boekel Industries, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823766 is the FDA 510(k) clearance record for BLOOD GAS INCUBATOR #260650, a class I device, cleared for Boekel Industries, Inc. on under FDA product code JRG (Block, Heating). FDA records list 3 510(k) clearances for Boekel Industries, Inc., from to . As of , FDA records show no recalls naming K823766.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JRG Block, Heating
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boekel Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JRG

Trailing 12 months

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

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