Cleared Traditional

K182543 - Wearable Device (FDA 510(k) Clearance)

Also includes:
Cradle Small Strap, Medium Strap, Large Strap Multiple Device Charger Hospital Starter Package

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

K182543 · Snap40, Ltd. · Cardiovascular device
Nov 2018
Decision
58d
Days
Class 2
Risk

K182543 is an FDA 510(k) clearance for the Wearable Device. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Snap40, Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on November 14, 2018 after a review of 58 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.

Submission Details

510(k) Number K182543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date November 14, 2018
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
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 Peers - MSX System, Network And Communication, Physiological Monitors

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