Cleared Traditional

K011518 - VITALSAT SERIES

K011518 is an FDA 510(k) clearance for VITALSAT SERIES, 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 547-day FDA review.

K011518 · Beta Biomed Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
547d
Days
Class 2
Risk

K011518 is an FDA 510(k) clearance for the VITALSAT SERIES. 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 November 15, 2002 after a review of 547 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K011518

510(k) Number K011518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2001
Decision Date November 15, 2002
Days to Decision 547 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
407d slower than avg
Panel avg: 140d · This submission: 547d
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 K011518.
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
K024235 · Dolphin Medical, Inc. · Mar 2003
IM2001 PULSE OXIMETER
K012706 · Imagyn Medical Technologies, Inc. · Mar 2003
MINOLTA PULSOX-2
K021469 · Konica Minolta Sensing, Inc. · Feb 2003
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER
K014218 · Dolphin Medical, Inc. · Nov 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K021955 · Datex-Ohmeda, Inc. · Oct 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · Welch Allyn, Inc. · Sep 2002
K011518 · VITALSAT SERIES
Download PDF FDA Summary Beta Biomed Services,…