510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091732Substantially Equivalent

Vrlxp, Model Xp

Deep Breeze, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091732 is the FDA 510(k) clearance record for VRLXP, MODEL XP, a class II device, cleared for Deep Breeze , Ltd. on under FDA product code OCR (Lung Sound Monitor). FDA's definition for product code OCR reads: "The lung sound monitor is intended for use in monitoring and recording lung sounds". FDA records list 3 510(k) clearances for Deep Breeze , Ltd., from to . As of , FDA records show no recalls naming K091732.

Clearance record

Decision date
Received
(266 days to decision)
Product code
OCR Lung Sound Monitor
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Deep Breeze , Ltd. 2001 Pennsylvania Ave. NW, Suite 950, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCR

Trailing 12 months

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

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