510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862023Substantially Equivalent

Spiromate as-600

Riko Medical & Scientific Instrument Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862023 is the FDA 510(k) clearance record for SPIROMATE AS-600, a class II device, cleared for Riko Medical & Scientific Instrument Corp. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 3 510(k) clearances for Riko Medical & Scientific Instrument Corp., from to . As of , FDA records show no recalls naming K862023.

Clearance record

Decision date
Received
(20 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Riko Medical & Scientific Instrument Corp. 3000 Marcus Ave., Lake Success NY
Third party review
No

Clearances, product code BZG

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