510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221802Substantially Equivalent

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Mawi DNA Technologies, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221802 is the FDA 510(k) clearance record for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL), a class II device, cleared for Mawi Dna Technologies on under FDA product code QBD (Microbial Nucleic Acid Storage And Stabilization Device). FDA's definition for product code QBD reads: "Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material". FDA records list one 510(k) clearance for Mawi Dna Technologies. As of , FDA records show no recalls naming K221802.

Clearance record

Decision date
Received
(286 days to decision)
Product code
QBD Microbial Nucleic Acid Storage And Stabilization Device
Regulation
21 CFR 866.2950
Device class
Class II
Review panel
Microbiology
Applicant
Mawi Dna Technologies 26203 Production Ave. Suite 3, Hayward CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBD

Trailing 12 months

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

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