510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830229Substantially Equivalent

Roentgenography Set

Mallinckrodt Critical Care, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830229 is the FDA 510(k) clearance record for ROENTGENOGRAPHY SET, a class II device, cleared for Mallinckrodt Critical Care on under FDA product code DGD (Igg, Ferritin, Antigen, Antiserum, Control). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K830229.

Clearance record

Decision date
Received
(44 days to decision)
Product code
DGD Igg, Ferritin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Mallinckrodt Critical Care 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DGD

Trailing 12 months

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

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