Cleared Traditional

K003542 - PREAMP CABLE, MODEL B400-1011PA

K003542 is an FDA 510(k) clearance for PREAMP CABLE, manufactured by Beta Biomed Services, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K003542 · Beta Biomed Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
140d
Days
Class 2
Risk

K003542 is an FDA 510(k) clearance for the PREAMP CABLE, MODEL B400-1011PA. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beta Biomed Services, Inc. (Crofton, US). The FDA issued a Cleared decision on April 6, 2001 after a review of 140 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K003542

510(k) Number K003542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date April 06, 2001
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K003542.
SPO2 WRAP SENSOR
K002848 · Epic Medical Equipment Services, Inc. · May 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · Novametrix Medical Systems, Inc. · Apr 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
K002036 · Osi Medical, Inc. · Apr 2001
FINGER PULSE METER
K000814 · Bhs Intl., Inc. · Mar 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · Datex-Ohmeda, Inc. · Mar 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K010419 · Masimo Corp. · Mar 2001
K003542 · PREAMP CABLE, MODEL B400-1011PA
Download PDF Beta Biomed Services,…