510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881141Substantially Equivalent

Pharmaseal Isoflex Anesthesia Breathing Circuit

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881141 is the FDA 510(k) clearance record for PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT, a class I device, cleared for Baxter Healthcare Corp on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K881141.

Clearance record

Decision date
Received
(39 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
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
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