510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771516Substantially Equivalent

Capillary Sample Line

Mcgaw Respiratory Therapy, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771516 is the FDA 510(k) clearance record for CAPILLARY SAMPLE LINE, a class II device, cleared for Mcgaw Respiratory Therapy on under FDA product code CCI (Analyzer, Gas, Nitrogen, Gaseous-Phase). FDA records list 8 510(k) clearances for Mcgaw Respiratory Therapy, from to . As of , FDA records show no recalls naming K771516.

Clearance record

Decision date
Received
(8 days to decision)
Product code
CCI Analyzer, Gas, Nitrogen, Gaseous-Phase
Regulation
21 CFR 868.1690
Device class
Class II
Review panel
Anesthesiology
Applicant
Mcgaw Respiratory Therapy 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CCI

Trailing 12 months

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

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