Cleared Traditional

K883158 - RESPIRATORY AIRWAY TUBE MONITOR (RATM)

K883158 is the FDA 510(k) clearance for RESPIRATORY AIRWAY TUBE MONITOR (RATM) by Vascucare, Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K883158 · Vascucare, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
223d
Days
Class 2
Risk

K883158 is an FDA 510(k) clearance for the RESPIRATORY AIRWAY TUBE MONITOR (RATM). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Vascucare, Inc. (Orangeburg, US). The FDA issued a Cleared decision on March 6, 1989 after a review of 223 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascucare, Inc. devices

Submission Details

510(k) Number K883158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date March 06, 1989
Days to Decision 223 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 39
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K883158.
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · Medtronic Vascular · Aug 1991
R-BAND(TM) RESPIRATORY SENSOR
K900264 · Buckman Co., Inc. · Jul 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986