Cleared Traditional

K083448 - CABLE

K083448 is an FDA 510(k) clearance for CABLE, manufactured by Conmed Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K083448 · Conmed Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
272d
Days
Class 2
Risk

K083448 is an FDA 510(k) clearance for the CABLE, TRANSDUCER, MODEL 2400GN. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 272 days - an extended review 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: 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 Conmed Corporation devices

FDA 510(k) Submission Details - K083448

510(k) Number K083448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date August 20, 2009
Days to Decision 272 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
132d slower than avg
Panel avg: 140d · This submission: 272d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K083448.
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
K091787 · Ivy Biomedical Systems, Inc. · 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
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
K090662 · Masimo Corporation · Aug 2009
MD300K1 PULSE OXIMETER
K090599 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2009
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
K090165 · Masimo Corporation · Jul 2009