FDA product code LZG: Pump, Infusion, Insulin
LZG is the FDA product code for pump, infusion, insulin. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel. FDA has cleared 85 510(k) submissions under LZG, 6 in the last five years, from 29 different applicants. The average 510(k) review took 133 days (median 109); 118 days on average over the last three years. FDA has posted 126 recalls for LZG devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Insulin |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for LZG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 245 |
| 2018 | 1 | 144 |
| 2019 | 2 | 66 |
| 2021 | 1 | 84 |
| 2022 | 1 | 392 |
| 2023 | 1 | 171 |
| 2024 | 2 | 128 |
| 2026 | 2 | 107 |
Compare with all 510(k) review times · Search every LZG clearance
Top LZG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Minimed | 14 | 2024-07-02 |
| Insulet Corporation | 12 | 2023-04-24 |
| Tandem Diabetes Care, Inc. | 7 | 2016-10-25 |
| Animas Corp. | 7 | 2008-06-24 |
| Disetronic Medical Systems AG | 6 | 2006-06-15 |
24 more applicants have LZG clearances. See the full list in Caduvo.
Most recent LZG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262153 | Modular Medical, Inc. | Pivot Insulin Delivery System | 2026-09-02 | 68 |
| K253534 | Modular Medical | Pivot Insulin Delivery System | 2026-04-08 | 146 |
| K240158 | Modular Medical, Inc. | Modular Medical MODD1 Insulin Delivery System | 2024-09-04 | 229 |
| K241622 | Medtronic Minimed | Extended Reservoir; MiniMed Reservoir | 2024-07-02 | 27 |
| K223372 | Insulet Corporation | Omnipod GO Insulin Delivery Device | 2023-04-24 | 171 |
Recalls for LZG devices
126 product recalls in 58 recall events; 5 initiated in the last five years and 11 still open. Most recent: 2026-05-20.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 11 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 3 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code LZG?
LZG is the FDA product code for pump, infusion, insulin. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel.
What device class is LZG?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZG?
Across 85 cleared submissions the average was 133 days from receipt to decision (median 109).
Which companies have the most LZG clearances?
Medtronic Minimed (14); Insulet Corporation (12); Tandem Diabetes Care, Inc. (7); Animas Corp. (7); Disetronic Medical Systems AG (6).
Have LZG devices been recalled?
Yes: 126 product recalls across 58 recall events; the most recent began 2026-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LZG
- Run a recall and safety report across every LZG manufacturer
- Watch product code LZG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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