FDA product code · General, Plastic Surgery · Class U
LCJ: Tissue Expander And Accessories
LCJ is FDA's product code for "Tissue Expander And Accessories": a Class U device, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.
510(k) review time for LCJ
Across 10 510(k) clearances under LCJ decided from 2018-01-01 to 2026-10-06, the median was 122 days from FDA receipt to decision. Half took between 29 and 357 days, and 80% were decided within 415 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 29 |
| Median | 122 |
| 75th percentile | 357 |
| 80th percentile | 415 |
| 90th percentile | 559 |
| Slowest | 864 |
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.
LCJ in the public FDA record
| 510(k) clearances, all years | 55 |
|---|---|
| Device recalls | 21 |
| GUDID device identifiers | 2,298 |
Counts of records, not of devices or events. Adverse event reports for LCJ 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 LCJ
2 FDA recognized consensus standards cite LCJ, 1 of them recognized only in part, among them ASTM F1441-03 (Reapproved 2022); ISO 14607 Fourth edition 2024-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-110 ASTM F1441-03 (Reapproved 2022) — Standard Specification for Soft-Tissue Expander Devices
- 6-513 ISO 14607 Fourth edition 2024-12 (partial recognition) — Non-active surgical implants - Mammary implants - Specific requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.