510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960218Substantially Equivalent

Connecting Tubing

Custom Pack Reliability, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960218 is the FDA 510(k) clearance record for CONNECTING TUBING, a class II device, cleared for Custom Pack Reliability on under FDA product code BYY (Tube, Aspirating, Flexible, Connecting). FDA records list 21 510(k) clearances for Custom Pack Reliability, from to . As of , FDA records show no recalls naming K960218.

Clearance record

Decision date
Received
(72 days to decision)
Product code
BYY Tube, Aspirating, Flexible, Connecting
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Custom Pack Reliability 4207 Vineland Rd., M-1, Orlando FL
510(k) summary
Statement
Third party review
No

Clearances, product code BYY

Trailing 12 months

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

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