510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070163Substantially Equivalent

Swabbable Cap, Model 60205

Baxa Corp., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070163 is the FDA 510(k) clearance record for SWABBABLE CAP, MODEL 60205, a class II device, cleared for Baxa Corp. on under FDA product code ODI (Administration Set Docking Station). FDA's definition for product code ODI reads: "Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set". FDA records list 7 510(k) clearances for Baxa Corp., from to . As of , FDA records show no recalls naming K070163.

Clearance record

Decision date
Received
(198 days to decision)
Product code
ODI Administration Set Docking Station
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxa Corp. 14445 Grasslands Dr., Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODI

Trailing 12 months

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

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