Cleared Traditional

K901548 - BIOMEDICAL SENSORS-SHILEY BGM 4000 INTR...

K901548 is an FDA 510(k) clearance for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTR..., manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code CCC cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K901548 · Shiley, Inc. · Anesthesiology device
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Jan 1991
Decision
286d
Days
Class 2
Risk

K901548 is an FDA 510(k) clearance for the BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 286 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1150 - 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K901548

510(k) Number K901548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date January 14, 1991
Days to Decision 286 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
146d slower than avg
Panel avg: 140d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCC Device Classification - Class 2, Special Controls

Product Code CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1150
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 - CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

Devices cleared under the same product code (CCC) and FDA review panel - the closest regulatory comparables to K901548.
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · Medtronic Vascular · Aug 1989
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911 · American Bentley · May 1987
OXYGEN ANALYZER 110
K780185 · Siemens Corp. · Mar 1978
SENSOMAT
K771722 · Biochem International, Inc. · Sep 1977
ANALYZER, SENTORR BLOOD GAS
K760088 · Ohio Medical Products · Aug 1976