510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093126Substantially Equivalent

Anapnoguard Endotracheal Tube

Hospitech Respiration, Binyamina, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093126 is the FDA 510(k) clearance record for ANAPNOGUARD ENDOTRACHEAL TUBE, a class I device, cleared for Hospitech Respiration , Ltd. on under FDA product code BTP (Dropper, Ether). FDA records list 6 510(k) clearances for Hospitech Respiration , Ltd., from to . As of , FDA records show no recalls naming K093126.

Clearance record

Decision date
Received
(151 days to decision)
Product code
BTP Dropper, Ether
Regulation
21 CFR 868.5420
Device class
Class I
Review panel
Anesthesiology
Applicant
Hospitech Respiration , Ltd. 31 Haavoda St., Binyamina, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTP

Trailing 12 months

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

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