510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770549Substantially Equivalent

Pediatric Anesthesia Circuit

Inspiron Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770549 is the FDA 510(k) clearance record for PEDIATRIC ANESTHESIA CIRCUIT, a class I device, cleared for Inspiron Corp. on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 20 510(k) clearances for Inspiron Corp., from to . As of , FDA records show no recalls naming K770549.

Clearance record

Decision date
Received
(9 days to decision)
Product code
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Regulation
21 CFR 868.5240
Device class
Class I
Review panel
Anesthesiology
Applicant
Inspiron Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CAI

Trailing 12 months

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

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