510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K883158Substantially Equivalent

Respiratory Airway Tube Monitor (Ratm)

Vascucare, Inc., Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883158 is the FDA 510(k) clearance record for RESPIRATORY AIRWAY TUBE MONITOR (RATM), a class II device, cleared for Vascucare, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 3 510(k) clearances for Vascucare, Inc., from to . As of , FDA records show no recalls naming K883158.

Clearance record

Decision date
Received
(223 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Vascucare, Inc. 40 Ramland Rd. S., Orangeburg NY
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260