Cleared Special

K182220 - Curbell branded Patient Monitoring Cables

K182220 is the FDA 510(k) clearance for Curbell branded Patient Monitoring Cables by Curbell Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code DSA) cleared through the Special 510(k) pathway after a 84-day FDA review.

K182220 · Curbell Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
84d
Days
Class 2
Risk

K182220 is an FDA 510(k) clearance for the Curbell branded Patient Monitoring Cables. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Curbell Medical Products, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 7, 2018 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2900 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Curbell Medical Products, Inc. devices

Submission Details

510(k) Number K182220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date November 07, 2018
Days to Decision 84 days
Submission Type Special
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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 47
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K182220.
Multi-Link X2 ECG and SpO2 Adapter
K191273 · Vyaire Medical, Inc. · Sep 2019
IntraSight
K190078 · Volcano Corporation · Feb 2019
Patient Cables and Leadwires , Disposable ECG Leadwires
K182327 · Orantech, Inc. · Jan 2019
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017