510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112562Substantially Equivalent

Bal Cath Bronchial Aspirate Sampling Catheter

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112562 is the FDA 510(k) clearance record for BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER, a class I device, cleared for Kimberly-Clark on under FDA product code OYI (Non-Bronchoscopic Bronchoalveolar Lavage Catheter). FDA's definition for product code OYI reads: "To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation". FDA records list 122 510(k) clearances for Kimberly-Clark, from to . As of , FDA records show no recalls naming K112562.

Clearance record

Decision date
Received
(80 days to decision)
Product code
OYI Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Kimberly-Clark 1400 Holcomb Bridge Rd., Roswell GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYI

Trailing 12 months

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

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