Cleared Traditional

K091787 - MODEL 6000 TWO PARAMETER BEDSIDE MONITOR

K091787 is an FDA 510(k) clearance for MODEL 6000 TWO PARAMETER BEDSIDE MONITOR, manufactured by Ivy Biomedical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K091787 · Ivy Biomedical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
114d
Days
Class 2
Risk

K091787 is an FDA 510(k) clearance for the MODEL 6000 TWO PARAMETER BEDSIDE MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 114 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.

View all Ivy Biomedical Systems, Inc. devices

FDA 510(k) Submission Details - K091787

510(k) Number K091787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date October 09, 2009
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
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 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K091787.
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER
K091241 · Masimo Corporation · Nov 2009
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
K092101 · Nonin Medical, Inc. · Oct 2009
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
K092838 · Masimo Corporation · Oct 2009
EVISION DATA MANAGEMENT SOFTWARE
K092678 · Nonin Medical, Inc. · Oct 2009
DISPOSABLE SPO2 SENSOR M1134A
K091572 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Sep 2009
CABLE, TRANSDUCER, MODEL 2400GN
K083448 · Conmed Corporation · Aug 2009