510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980381Substantially Equivalent

Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro

Carmel Pharma AB., Gothenburg, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980381 is the FDA 510(k) clearance record for PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO, a class II device, cleared for Carmel Pharma Ab. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 7 510(k) clearances for Carmel Pharma Ab., from to . As of , FDA records show no recalls naming K980381.

Clearance record

Decision date
Received
(29 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
Carmel Pharma Ab. Box 5352, Gothenburg, SE
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