Cleared Traditional

K173197 - Reusable NIBP Cuff (FDA 510(k) Clearance)

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

K173197 · Orantech, Inc. · Cardiovascular device
Aug 2018
Decision
323d
Days
Class 2
Risk

K173197 is an FDA 510(k) clearance for the Reusable NIBP Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Orantech, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 21, 2018 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

Submission Details

510(k) Number K173197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date August 21, 2018
Days to Decision 323 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 140d · This submission: 323d
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

Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K173197.
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
K253089 · Shenzhen Best Electronics Co., Ltd. · Feb 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · Unimed Medical Supplies, Inc. · Jan 2026
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · Baxter Healthcare Corporation · Dec 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · Unimed Medical Supplies, Inc. · Jul 2025
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023