510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080484Substantially Equivalent

Inomax Ds (Delivery System), Model 10003

Mallinckrodt Manufacturing LLC, Clinton NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080484 is the FDA 510(k) clearance record for INOMAX DS (DELIVERY SYSTEM), MODEL 10003, a class II device, cleared for Ino Therapeutics on under FDA product code MRN (Apparatus, Nitric Oxide Delivery). FDA records list 19 510(k) clearances for Mallinckrodt Manufacturing LLC, from to . As of , FDA records show no recalls naming K080484.

Clearance record

Decision date
Received
(166 days to decision)
Product code
MRN Apparatus, Nitric Oxide Delivery
Regulation
21 CFR 868.5165
Device class
Class II
Review panel
Anesthesiology
Applicant
Ino Therapeutics 6 Rte. 173, Clinton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRN

Trailing 12 months

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

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