510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K853433Substantially Equivalent

Elf

Cardio-Respiratory, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853433 is the FDA 510(k) clearance record for ELF, a class II device, cleared for Cardio-Respiratory on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list one 510(k) clearance for Cardio-Respiratory. As of , FDA records show no recalls naming K853433.

Clearance record

Decision date
Received
(106 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Cardio-Respiratory Johnson, Johnson & Johnson, Dallas TX
Third party review
No

Clearances, product code BTY

Trailing 12 months
1 clearance under product code BTY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260