Cleared Special

K182821 - Accutorr 7/VS-900/VS-900c Vital Signs Monitor

K182821 is an FDA 510(k) clearance for Accutorr 7/VS-900/VS-900c Vital Signs M..., manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 174-day FDA review.

K182821 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
174d
Days
Class 2
Risk

K182821 is an FDA 510(k) clearance for the Accutorr 7/VS-900/VS-900c 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 March 27, 2019 after a review of 174 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182821

510(k) Number K182821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2018
Decision Date March 27, 2019
Days to Decision 174 days
Submission Type Special
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
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Modification to existing cleared device.

MWI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 308
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K182821 · Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Download PDF FDA Summary Shenzhen Mindray Bio-…