Cleared Traditional

K900264 - R-BAND(TM) RESPIRATORY SENSOR

K900264 is the FDA 510(k) clearance for R-BAND(TM) RESPIRATORY SENSOR by Buckman Co., Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K900264 · Buckman Co., Inc. · Anesthesiology device
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Jul 1990
Decision
187d
Days
Class 2
Risk

K900264 is an FDA 510(k) clearance for the R-BAND(TM) RESPIRATORY SENSOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 24, 1990 after a review of 187 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K900264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1990
Decision Date July 24, 1990
Days to Decision 187 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 140d · This submission: 187d
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 65
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K900264.
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
MEDICAL SAFETY CABLE AND LEAD SYSTEM
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MODEL 900S APNEA/HEART MONITOR
K903287 · Healthdyne, Inc. · Aug 1990
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · S & W Medico Teknik · Jul 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
HEALTHDYNE RATE METER
K874814 · Healthdyne, Inc. · Feb 1988