Cleared Traditional

K153251 - Tenso TS-101S and TS-101D Disposable Bl...

K153251 is the FDA 510(k) clearance for Tenso TS-101S and TS-101D Disposable Bl... by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K153251 · Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. · Cardiovascular device
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Apr 2016
Decision
156d
Days
Class 2
Risk

K153251 is an FDA 510(k) clearance for the Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on April 14, 2016 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. devices

Submission Details

510(k) Number K153251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2015
Decision Date April 14, 2016
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K153251.
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Medline Singe Patient Use Blood Pressure Cuff
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Cogent Hemodynamic Monitoring System
K152006 · Icu Medical, Inc. · May 2016
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012