510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964989Substantially Equivalent

Cdc Vial and Bag Access Pin (Cdc-P-1/P-2/P-3/P-4/P-5)

Critical Device Corp., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964989 is the FDA 510(k) clearance record for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5), a class II device, cleared for Critical Device Corp. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 6 510(k) clearances for Critical Device Corp., from to . As of , FDA records show no recalls naming K964989.

Clearance record

Decision date
Received
(110 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Critical Device Corp. 499 Nibus St., Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260