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FDA product code · Ear, Nose, Throat · Class 2

KLW: Masker, Tinnitus

KLW is FDA's product code for "Masker, Tinnitus": a Class 2 device classified under 21 CFR 874.3400, reviewed by the Ear, Nose, Throat panel.

510(k) review time for KLW

Across 10 510(k) clearances under KLW decided from 2018-01-01 to 2026-10-06, the median was 161 days from FDA receipt to decision. Half took between 89 and 247 days, and 80% were decided within 264 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KLW, decisions 2018-01-01 to 2026-10-06 (n = 10)
Fastest28
25th percentile89
Median161
75th percentile247
80th percentile264
90th percentile278
Slowest285

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.

KLW in the public FDA record

Records naming KLW, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years78
GUDID device identifiers17,546

Counts of records, not of devices or events. Adverse event reports for KLW 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 KLW

6 FDA recognized consensus standards cite KLW, among them ANSI ASA S3.1-1999 (Reaffirmed 2023); ANSI ASA S3.4-2007 (Reaffirmed 2025); ANSI ASA S3.21-2004 (Reaffirmed 2023). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 4-160 ANSI ASA S3.1-1999 (Reaffirmed 2023) — American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
  • 4-162 ANSI ASA S3.4-2007 (Reaffirmed 2025) — American National Standard Procedure for the Computation of Loudness of Steady Sounds
  • 4-167 ANSI ASA S3.21-2004 (Reaffirmed 2023) — American National Standard Methods for Manual Pure-Tone Threshold Audiometry
  • 4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006) — American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
  • 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2025) — American National Standard Bioacoustical Terminology
  • 4-260 ANSI ASA S12.2-2019 (Reaffirmed 2023) — American National Standard for Criteria for Evaluating Room Noise

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

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