Cleared Traditional

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P (K092549) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092549 · Bio Medical Technologies Co., Ltd. · Anesthesiology device
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Nov 2009
Decision
89d
Days
Class 2
Risk

K092549 is an FDA 510(k) clearance for the OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bio Medical Technologies Co., Ltd. (Dunwoody, US). The FDA issued a Cleared decision on November 16, 2009 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio Medical Technologies Co., Ltd. devices

Submission Details

510(k) Number K092549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date November 16, 2009
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 203
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K092549.
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H100B PULSE OXIMETER
K092727 · Edan Instruments, Inc. · Dec 2009
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008