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FDA product code · Physical Medicine · Class 2

IPF: Stimulator, Muscle, Powered

IPF is FDA's product code for "Stimulator, Muscle, Powered": a Class 2 device classified under 21 CFR 890.5850, reviewed by the Physical Medicine panel.

510(k) review time for IPF

Across 62 510(k) clearances under IPF decided from 2018-01-01 to 2026-10-06, the median was 135 days from FDA receipt to decision. Half took between 88 and 260 days, and 80% were decided within 285 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, IPF, decisions 2018-01-01 to 2026-10-06 (n = 62)
Fastest21
25th percentile88
Median135
75th percentile260
80th percentile285
90th percentile332
Slowest750
Median days by decision year, IPF (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2018735
20201219
20219815
20221087
20232559
20242017

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.

IPF in the public FDA record

Records naming IPF, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years548
Establishment listings348
GUDID device identifiers956

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

2 FDA recognized consensus standards cite IPF, among them IEC 60601-2-10 Edition 2.1 2016-04; IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 17-16 IEC 60601-2-10 Edition 2.1 2016-04 — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
  • 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

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

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