510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K892121Substantially Equivalent

Spiro-Link Real Time Spirometry System

Biocom Intl., Inc., Puyallup WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892121 is the FDA 510(k) clearance record for SPIRO-LINK REAL TIME SPIROMETRY SYSTEM, a class II device, cleared for Biocom Intl., Inc. on under FDA product code BZC (Calculator, Pulmonary Function Data). FDA records list one 510(k) clearance for Biocom Intl., Inc. As of , FDA records show no recalls naming K892121.

Clearance record

Decision date
Received
(77 days to decision)
Product code
BZC Calculator, Pulmonary Function Data
Regulation
21 CFR 868.1880
Device class
Class II
Review panel
Anesthesiology
Applicant
Biocom Intl., Inc. 12201 133rd Ave. E., Puyallup WA
Third party review
No

Clearances, product code BZC

Trailing 12 months

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

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