510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132709Substantially Equivalent

Vr Medical Heat and Moisture Exchanger and Filter

Vr Medical, Kunshan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132709 is the FDA 510(k) clearance record for VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER, a class II device, cleared for Vr Medical on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 2 510(k) clearances for Vr Medical, from to . As of , FDA records show no recalls naming K132709.

Clearance record

Decision date
Received
(335 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Vr Medical 90 Gaoxin Rd., Zhouzhuang, Kunshan, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAH

Trailing 12 months
2 clearances under product code CAH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260