510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864588Substantially Equivalent

Penlon Circle System

Bear Medical Systems, Inc., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864588 is the FDA 510(k) clearance record for PENLON CIRCLE SYSTEM, a class I device, cleared for Bear Medical Systems, Inc. on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 28 510(k) clearances for Bear Medical Systems, Inc., from to . As of , FDA records show no recalls naming K864588.

Clearance record

Decision date
Received
(74 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
Bear Medical Systems, Inc. 2085 Rustin Ave., Riverside 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