510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791294Substantially Equivalent

Spirocal

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

K791294 is the FDA 510(k) clearance record for SPIROCAL, a class I device, cleared for Equilibrated Bio Systems, Inc. on under FDA product code BXX (Calibrator, Pressure, Gas). FDA records list 7 510(k) clearances for Equilibrated Bio Systems, Inc., from to . As of , FDA records show no recalls naming K791294.

Clearance record

Decision date
Received
(37 days to decision)
Product code
BXX Calibrator, Pressure, Gas
Regulation
21 CFR 868.2620
Device class
Class I
Review panel
Anesthesiology
Applicant
Equilibrated Bio Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXX

Trailing 12 months

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

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