510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102229Substantially Equivalent

Pulmotrack 2020 System

Karmelsonix, Binyamina, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102229 is the FDA 510(k) clearance record for PULMOTRACK 2020 SYSTEM, a class II device, cleared for Karmelsonix on under FDA product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)). FDA records list 4 510(k) clearances for Karmelsonix, from to . As of , FDA records show no recalls naming K102229.

Clearance record

Decision date
Received
(207 days to decision)
Product code
BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Karmelsonix 31 Haavoda St., Binyamina, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZM

Trailing 12 months

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

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