Cleared Traditional

PCA-C1 series Patient Cable (K200722) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200722 · QT Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
441d
Days
Class 2
Risk

K200722 is an FDA 510(k) clearance for the PCA-C1 series Patient Cable. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by QT Medical, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on June 3, 2021 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight 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 Cardiovascular submissions.

View all QT Medical, Inc. devices

Submission Details

510(k) Number K200722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2020
Decision Date June 03, 2021
Days to Decision 441 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 125d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 40
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K200722.
9Line
K211941 · Energetic Designs, Inc. · Jan 2022
Multi-Link X2 ECG Cable and Leadwire System
K211294 · Vyaire Medical, Inc. · Aug 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · Medtronic, Inc. · Jul 2021
Patient Monitoring Cables
K203635 · Jkh USA, LLC · Feb 2021
Multi-LinkTM X2 ECG Adapter and Leadwires
K200510 · Vyaire Medical, Inc. · Oct 2020
ECG Cables and Leadwires
K201359 · Xinkang Medical Instrument Co. , Ltd. · Oct 2020