FDA product code · General, Plastic Surgery · Class 2
JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered
JCX is FDA's product code for "Apparatus, Suction, Ward Use, Portable, Ac-Powered": a Class 2 device classified under 21 CFR 878.4780, reviewed by the General, Plastic Surgery panel.
510(k) review time for JCX
Across 11 510(k) clearances under JCX decided from 2018-01-01 to 2026-10-06, the median was 55 days from FDA receipt to decision. Half took between 28 and 195 days, and 80% were decided within 200 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 28 |
| Median | 55 |
| 75th percentile | 195 |
| 80th percentile | 200 |
| 90th percentile | 304 |
| Slowest | 406 |
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.
JCX in the public FDA record
| 510(k) clearances, all years | 77 |
|---|---|
| Device recalls | 24 |
| Establishment listings | 99 |
Counts of records, not of devices or events. Adverse event reports for JCX 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 JCX
3 FDA recognized consensus standards cite JCX, among them ISO 10079-1 Fourth edition 2022-03; ISO 10079-4 First edition 2021-08; ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026]. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-157 ISO 10079-1 Fourth edition 2022-03 — Medical suction equipment - Part 1: Electrically powered suction equipment
- 1-158 ISO 10079-4 First edition 2021-08 — Medical suction equipment - Part 4: General requirements
- 1-203 ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026] — Medical suction equipment - Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.