Cleared Traditional

K242193 - Arm Type Blood Pressure Monitor (BPM82)

K242193 is the FDA 510(k) clearance for Arm Type Blood Pressure Monitor (BPM82) by Avita Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K242193 · Avita Corporation · Cardiovascular device
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Oct 2024
Decision
88d
Days
Class 2
Risk

K242193 is an FDA 510(k) clearance for the Arm Type Blood Pressure Monitor (BPM82). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on October 22, 2024 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avita Corporation devices

Submission Details

510(k) Number K242193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2024
Decision Date October 22, 2024
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K242193.
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
K242528 · Shenzhen Ruiankang Technology Co., Ltd. · Jan 2025
Arm Blood Pressure Monitor (model: BPM-A7VL)
K243118 · Shenzhen Imdk Medical Technology Co., Ltd. · Nov 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · Shenzhen Urion Technology Co., Ltd. · Oct 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
K241613 · Shenzhen Hbcare Technology Co.,Ltd · Oct 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
K242721 · Shenzhen Finicare Co., Ltd. · Oct 2024
Blood Pressure Monitor (TMB-2092-G)
K241351 · Guangdong Transtek Medical Electronics Co., Ltd. · Aug 2024