510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223625Substantially Equivalent

CapnoSpot™ Pneumothorax Decompression Indicator

Pneumeric, Inc., Rochester MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223625 is the FDA 510(k) clearance record for CapnoSpot™ Pneumothorax Decompression Indicator, a class I device, cleared for Pneumeric, Inc. on under FDA product code GAA (Needle, Aspiration And Injection, Disposable). FDA records list one 510(k) clearance for Pneumeric, Inc. As of , FDA records show no recalls naming K223625.

Clearance record

Decision date
Received
(113 days to decision)
Product code
GAA Needle, Aspiration And Injection, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pneumeric, Inc. 823 4th St. SW, C/O Johnathon Aho, Rochester MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAA

Trailing 12 months

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

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