Cleared Traditional

K180380 - vital signs monitor

K180380 is the FDA 510(k) clearance for vital signs monitor by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DQA) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K180380 · Edan Instruments, Inc. · Cardiovascular device
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Dec 2018
Decision
312d
Days
Class 2
Risk

K180380 is an FDA 510(k) clearance for the vital signs monitor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 21, 2018 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K180380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date December 21, 2018
Days to Decision 312 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
187d slower than avg
Panel avg: 125d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Edan Medical
Doug Worth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K180380.
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
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oCare Wrist Pulse Oximeter
K183556 · Taiwan Biophotonic Corporation · Feb 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · Masimo Corporation · Jan 2019
AS-3XX Series Fingertip Pulse Oximeter
K180685 · Xiamen Acurio Instruments Co., Ltd. · Nov 2018
Handheld Pulse Oximeter, Model SP-20
K172792 · Shenzhen Creative Industry Co., Ltd. · Nov 2018
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K180046 · Masimo Corporation · Oct 2018