510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771510Substantially Equivalent

Servo-Pak Molel 0030

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

K771510 is the FDA 510(k) clearance record for SERVO-PAK MOLEL 0030, a class I device, cleared for Isothermal Systems, Inc. on under FDA product code BXA (Analyzer, Gas, Water Vapor, Gaseous-Phase). FDA records list 2 510(k) clearances for Isothermal Systems, Inc., from to . As of , FDA records show no recalls naming K771510.

Clearance record

Decision date
Received
(11 days to decision)
Product code
BXA Analyzer, Gas, Water Vapor, Gaseous-Phase
Regulation
21 CFR 868.1975
Device class
Class I
Review panel
Anesthesiology
Applicant
Isothermal Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXA

Trailing 12 months

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

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