510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K915287Substantially Equivalent

Isol-Aide

Computronic Systems, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915287 is the FDA 510(k) clearance record for ISOL-AIDE, a class II device, cleared for Computronic Systems on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list one 510(k) clearance for Computronic Systems. As of , FDA records show no recalls naming K915287.

Clearance record

Decision date
Received
(330 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Computronic Systems 7000 Granger Rd., Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code CBN

Trailing 12 months

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

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