Cleared Traditional

AirStrip RPM InvisionHeart Adapter (K182226) - FDA 510(k) Clearance

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

K182226 · Airstrip Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
26d
Days
Class 2
Risk

K182226 is an FDA 510(k) clearance for the AirStrip RPM InvisionHeart Adapter. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Airstrip Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 11, 2018 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Airstrip Technologies, Inc. devices

Submission Details

510(k) Number K182226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date September 11, 2018
Days to Decision 26 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 111
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K182226.
Handheld VitalSigns Monitoring System
K172965 · Visiomed Technology Co.,Ltd · Dec 2018
3880 MRI Patient Monitoring System
K182900 · Iradimed Corporation · Dec 2018
Unity Network ID
K183116 · Ge Healthcare · Dec 2018
Philips Hemodynamic Application R1.0
K181311 · Philips Medical Systems Nederlands B.V. · Sep 2018
SmartLinx Vitals Plus Patient Monitoring System
K180734 · Capsule Technologie · Aug 2018
VTRUST Vital Signs Monitor, Model: TD-2300
K172221 · Taidoc Technology Corporation · Jun 2018