Cleared Traditional

K221113 - Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor (FDA 510(k) Clearance)

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

K221113 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device

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Dec 2022

Decision

231d

Days

Class 2

Risk

K221113 is an FDA 510(k) clearance for the Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 2, 2022 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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. Standard predicate reliance. 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K221113 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 15, 2022
Decision Date	December 02, 2022
Days to Decision	231 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

106d slower than avg

Panel avg: 125d · This submission: 231d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.2300

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.