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FDA product code · Cardiovascular · Class 2

OCL: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

OCL is FDA's product code for "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue": a Class 2 device classified under 21 CFR 878.4400, reviewed by the Cardiovascular panel.

510(k) review time for OCL

Across 15 510(k) clearances under OCL decided from 2018-01-01 to 2026-10-06, the median was 89 days from FDA receipt to decision. Half took between 29 and 126 days, and 80% were decided within 143 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OCL, decisions 2018-01-01 to 2026-10-06 (n = 15)
Fastest23
25th percentile29
Median89
75th percentile126
80th percentile143
90th percentile203
Slowest242

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

OCL in the public FDA record

Records naming OCL, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years54
Device recalls17
Establishment listings97

Counts of records, not of devices or events. Adverse event reports for OCL are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite OCL

2 FDA recognized consensus standards cite OCL, 1 of them recognized only in part, among them IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 6-389 IEC 60601-2-2 Edition 6.0 2017-03 (partial recognition) — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • 6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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