FDA product code · General Hospital · Class 2
LGZ: Warmer, Thermal, Infusion Fluid
LGZ is FDA's product code for "Warmer, Thermal, Infusion Fluid": a Class 2 device classified under 21 CFR 880.5725, reviewed by the General Hospital panel.
510(k) review time for LGZ
Across 13 510(k) clearances under LGZ decided from 2018-01-01 to 2026-10-06, the median was 209 days from FDA receipt to decision. Half took between 90 and 340 days, and 80% were decided within 464 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 90 |
| Median | 209 |
| 75th percentile | 340 |
| 80th percentile | 464 |
| 90th percentile | 681 |
| Slowest | 740 |
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.
LGZ in the public FDA record
| 510(k) clearances, all years | 75 |
|---|---|
| Device recalls | 33 |
| Establishment listings | 114 |
| GUDID device identifiers | 598 |
Counts of records, not of devices or events. Adverse event reports for LGZ 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 LGZ
No FDA recognized consensus standard cites LGZ 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.