510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192595Substantially Equivalent

ExSpiron 2Xi

Respiratory Motion, Inc., Watertown MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192595 is the FDA 510(k) clearance record for ExSpiron 2Xi, a class II device, cleared for Respiratory Motion on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 5 510(k) clearances for Respiratory Motion, from to . As of , FDA records show no recalls naming K192595.

Clearance record

Decision date
Received
(88 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Respiratory Motion 80 Coolidge Hill Rd., Watertown MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZK

Trailing 12 months
1 clearance under product code BZK in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZK, 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 20261
October 20260