Cleared Traditional

K223873 - Boppli Infant Blood Pressure Monitor

K223873 is an FDA 510(k) clearance for Boppli Infant Blood Pressure Monitor, manufactured by Pyrames, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K223873 · Pyrames, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
280d
Days
Class 2
Risk

K223873 is an FDA 510(k) clearance for the Boppli Infant Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pyrames, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 29, 2023 after a review of 280 days - an extended review 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: 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 Pyrames, Inc. devices

FDA 510(k) Submission Details - K223873

510(k) Number K223873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2022
Decision Date September 29, 2023
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K223873.
Electronic Blood Pressure Monitor
K231310 · Shenzhen Jumper Medical Equipment Co., Ltd. · Oct 2023
Acumen IQ finger cuff
K230919 · Edwards Lifesciences, LLC · Oct 2023
Arm Blood Pressure Monitor
K231050 · Alicn Medical (Shenzhen), Inc. · Oct 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
K231367 · Shenzhen Finicare Co., Ltd. · Sep 2023
Arm Blood Pressure Monitor
K230649 · Alicn Medical (Shenzhen), Inc. · Sep 2023
Digital Blood Pressure Monitor WBP Series
K231542 · Weony (Shenzhen) Technology Co., Ltd. · Sep 2023