510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250940Substantially Equivalent

Atmo Gas Capsule System

Atmo Biosciences Ltd, Box Hill, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250940 is the FDA 510(k) clearance record for Atmo Gas Capsule System, a class II device, cleared for Atmo Biosciences, Ltd. on under FDA product code NYV (Gastrointestinal Motility System, Capsule). FDA's definition for product code NYV reads: "Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders". FDA records list 2 510(k) clearances for Atmo Biosciences, Ltd., from to . As of , FDA records show no recalls naming K250940.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NYV Gastrointestinal Motility System, Capsule
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Atmo Biosciences, Ltd. 436 Elgar Rd., Box Hill, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYV

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