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FDA product code · General, Plastic Surgery · Class 2

PBX: Massager, Vacuum, Radio Frequency Induced Heat

PBX is FDA's product code for "Massager, Vacuum, Radio Frequency Induced Heat": a Class 2 device classified under 21 CFR 878.4400, reviewed by the General, Plastic Surgery panel.

510(k) review time for PBX

Across 59 510(k) clearances under PBX decided from 2018-01-01 to 2026-10-06, the median was 180 days from FDA receipt to decision. Half took between 93 and 278 days, and 80% were decided within 305 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PBX, decisions 2018-01-01 to 2026-10-06 (n = 59)
Fastest29
25th percentile93
Median180
75th percentile278
80th percentile305
90th percentile410
Slowest715
Median days by decision year, PBX (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20191478
20201348
20211696
20223087
20232279
20241306
20252007
2026 (to 10-06, partial)1805

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.

PBX in the public FDA record

Records naming PBX, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years79
Establishment listings154

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

No FDA recognized consensus standard cites PBX by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

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

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