FDA product code · Clinical Chemistry · Class 2
LZG: Pump, Infusion, Insulin
LZG is FDA's product code for "Pump, Infusion, Insulin": a Class 2 device classified under 21 CFR 880.5725, reviewed by the Clinical Chemistry panel.
510(k) review time for LZG
Across 10 510(k) clearances under LZG decided from 2018-01-01 to 2026-10-06, the median was 125 days from FDA receipt to decision. Half took between 72 and 165 days, and 80% were decided within 183 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 72 |
| Median | 125 |
| 75th percentile | 165 |
| 80th percentile | 183 |
| 90th percentile | 245 |
| Slowest | 392 |
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.
LZG in the public FDA record
| 510(k) clearances, all years | 85 |
|---|---|
| Device recalls | 126 |
Counts of records, not of devices or events. Adverse event reports for LZG 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 LZG
6 FDA recognized consensus standards cite LZG, among them IEEE Std 11073-10419:2023; IEEE Std 11073-10419:2015; ISO 23908 First edition 2011-06-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-145 IEEE Std 11073-10419:2023 — Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
- 13-81 IEEE Std 11073-10419:2015 — Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
- 6-273 ISO 23908 First edition 2011-06-11 — Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling
- 6-422 AAMI TIR38:2019 — Medical device safety assurance case guidance
- 6-482 AAMI TIR101:2021 — Fluid delivery performance testing for infusion pumps
- 6-507 ISO 23908 Second Edition 2024-12 — Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.