Cleared Traditional

K234155 - Nimbl (model PD08-N1)

K234155 is an FDA 510(k) clearance for Nimbl (model PD08-N1), manufactured by Tactile Medical. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K234155 · Tactile Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
175d
Days
Class 2
Risk

K234155 is an FDA 510(k) clearance for the Nimbl (model PD08-N1). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tactile Medical (Minneapolis, US). The FDA issued a Cleared decision on June 21, 2024 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Tactile Medical devices

FDA 510(k) Submission Details - K234155

510(k) Number K234155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2023
Decision Date June 21, 2024
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 122
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K234155.
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