Cleared Traditional

Sight OLO (K211840) - FDA 510(k) Clearance

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

K211840 · S.D. Sight Diagnostics , Ltd. · Hematology device
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May 2022
Decision
329d
Days
Class 2
Risk

K211840 is an FDA 510(k) clearance for the Sight OLO. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by S.D. Sight Diagnostics , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 9, 2022 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all S.D. Sight Diagnostics , Ltd. devices

Submission Details

510(k) Number K211840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2021
Decision Date May 09, 2022
Days to Decision 329 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 113d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

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 - GKZ Counter, Differential Cell

All 126
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K211840.
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