510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864065Substantially Equivalent

Bks-42 Disposable Vacuum Tubing Pack

Allergan, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864065 is the FDA 510(k) clearance record for BKS-42 DISPOSABLE VACUUM TUBING PACK, a class I device, cleared for Allergan, Inc. on under FDA product code HNO (Keratome, Ac-Powered). FDA records list 39 510(k) clearances for Allergan, Inc., from to . As of , FDA records show no recalls naming K864065.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Allergan, Inc. Post Office Box 25155, Santa Ana CA
Third party review
No

Clearances, product code HNO

Trailing 12 months

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

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