510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K020102Substantially Equivalent

Iqteq Spirometer

Iqteq Development, Cape Town, Western Cape, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020102 is the FDA 510(k) clearance record for IQTEQ SPIROMETER, a class II device, cleared for Iqteq Development on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for Iqteq Development. As of , FDA records show no recalls naming K020102.

Clearance record

Decision date
Received
(434 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Iqteq Development Jaga Hose, 61 Wale St., Cape Town, Western Cape, ZA
510(k) summary
Summary PDF
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