510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050853Substantially Equivalent

Pmp4 Spiropro

Card Guard Scientific Survival, Ltd., Rehovot, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050853 is the FDA 510(k) clearance record for PMP4 SPIROPRO, a class II device, cleared for Card Guard Scientific Survival , Ltd. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 49 510(k) clearances for Card Guard Scientific Survival , Ltd., from to . As of , FDA records show no recalls naming K050853.

Clearance record

Decision date
Received
(30 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Card Guard Scientific Survival , Ltd. 2 Pekeris St., Rehovot, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZH

Trailing 12 months
2 clearances under product code BZH 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 BZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260