Cleared Traditional

K252762 - HALO AP Dx (FDA 510(k) Clearance)

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

K252762 · Indica Labs, LLC · Pathology device
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Nov 2025
Decision
88d
Days
Class 2
Risk

K252762 is an FDA 510(k) clearance for the HALO AP Dx. Classified as Digital Pathology Image Viewing And Management Software (product code QKQ), Class II - Special Controls.

Submitted by Indica Labs, LLC (Albuquerque, US). The FDA issued a Cleared decision on November 25, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device 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 Indica Labs, LLC devices

Submission Details

510(k) Number K252762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date November 25, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel Pathology (PA)
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 slower than avg
Panel avg: 77d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKQ Digital Pathology Image Viewing And Management Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition Digital Pathology Image Viewing And Management Software Device Is A Software Intended For Viewing And Management Of Digital Images Of Scanned Surgical Pathology Slides Prepared From Formalin-fixed Paraffin Embedded (ffpe) Tissue. It Is An Aid To The Pathologist To Review And Interpret These Digital Images For The Purposes Of Primary Diagnosis.
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 Pathology devices follow this clearance model.

Regulatory Peers - QKQ Digital Pathology Image Viewing And Management Software

All 12
Devices cleared under the same product code (QKQ) and FDA review panel - the closest regulatory comparables to K252762.
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