510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781454Substantially Equivalent

Linde Oxygen Concentrator Model Loc-Hca

Union Carbide Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781454 is the FDA 510(k) clearance record for LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA, a class II device, cleared for Union Carbide Corp. on under FDA product code CHW (Titrimetric With Edta And Indicator, Calcium). FDA records list 69 510(k) clearances for Union Carbide Corp., from to . As of , FDA records show no recalls naming K781454.

Clearance record

Decision date
Received
(29 days to decision)
Product code
CHW Titrimetric With Edta And Indicator, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Union Carbide Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CHW

Trailing 12 months

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

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