Cleared Traditional

K242487 - Laminar P1 (LDH-HW-001)

K242487 is an FDA 510(k) clearance for Laminar P1 (LDH-HW-001), manufactured by Laminar Digital Health, Inc.. The device is a Class 2 Cardiovascular device with product code JAF cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K242487 · Laminar Digital Health, Inc. · Cardiovascular device
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Dec 2024
Decision
114d
Days
Class 2
Risk

K242487 is an FDA 510(k) clearance for the Laminar P1 (LDH-HW-001). Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Laminar Digital Health, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 13, 2024 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1540 - 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 Laminar Digital Health, Inc. devices

FDA 510(k) Submission Details - K242487

510(k) Number K242487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2024
Decision Date December 13, 2024
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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

RQM+
Pierre Bounaud

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 - JAF Monitor, Ultrasonic, Nonfetal

All 7
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K242487.
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