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FDA product code · Gastroenterology, Urology · Class 2

MSD: Catheter, Hemodialysis, Implanted

MSD is FDA's product code for "Catheter, Hemodialysis, Implanted": a Class 2 device classified under 21 CFR 876.5540, reviewed by the Gastroenterology, Urology panel. FDA flags it as an implant and life-sustaining or life-supporting.

510(k) review time for MSD

Across 12 510(k) clearances under MSD decided from 2018-01-01 to 2026-10-06, the median was 138 days from FDA receipt to decision. Half took between 89 and 224 days, and 80% were decided within 255 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, MSD, decisions 2018-01-01 to 2026-10-06 (n = 12)
Fastest29
25th percentile89
Median138
75th percentile224
80th percentile255
90th percentile339
Slowest367

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.

MSD in the public FDA record

Records naming MSD, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years124
Device recalls270
Establishment listings336
GUDID device identifiers2,341

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

1 FDA recognized consensus standard cite MSD, among them AAMI TIR42:2021. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 3-172 AAMI TIR42:2021 — Evaluation of Particulates Associated with Vascular Medical Devices

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

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