FDA product code LGZ: Warmer, Thermal, Infusion Fluid
LGZ is the FDA product code for warmer, thermal, infusion fluid. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 76 510(k) submissions under LGZ, 9 in the last five years, from 50 different applicants. The average 510(k) review took 174 days (median 121); 152 days on average over the last three years. FDA has posted 33 recalls for LGZ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Thermal, Infusion Fluid |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for LGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 134 |
| 2018 | 1 | 98 |
| 2019 | 3 | 200 |
| 2022 | 3 | 499 |
| 2023 | 1 | 740 |
| 2024 | 1 | 322 |
| 2025 | 2 | 90 |
| 2026 | 2 | 44 |
Compare with all 510(k) review times · Search every LGZ clearance
Top LGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quality IN Flow , Ltd. | 5 | 2022-12-08 |
| Belmont Instrument Corp. | 5 | 2013-11-06 |
| STERIS Corporation | 3 | 2011-07-29 |
| Medical Solutions, Inc. | 3 | 2005-02-15 |
| C.F. Electronics, Inc. | 3 | 1996-05-14 |
45 more applicants have LGZ clearances. See the full list in Caduvo.
Most recent LGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262532 | ICU Medical | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | 2026-09-18 | 58 |
| K260988 | Mequ A/S | °M Warmer System with °M Station | 2026-04-24 | 30 |
| K252636 | The Surgical Company International B.V. | Fluido Compact System | 2025-11-18 | 90 |
| K251733 | The Surgical Company International BV (As Tsc Life) | Fluido® AirGuard System | 2025-09-04 | 90 |
| K232107 | Mequ A/S | °M Warmer System | 2024-05-31 | 322 |
Recalls for LGZ devices
33 product recalls in 19 recall events; 6 initiated in the last five years and 8 still open. Most recent: 2026-06-24.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2021 | 8 |
| 2025 | 5 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LGZ?
LGZ is the FDA product code for warmer, thermal, infusion fluid. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is LGZ?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGZ?
Across 76 cleared submissions the average was 174 days from receipt to decision (median 121).
Which companies have the most LGZ clearances?
Quality IN Flow , Ltd. (5); Belmont Instrument Corp. (5); STERIS Corporation (3); Medical Solutions, Inc. (3); C.F. Electronics, Inc. (3).
Have LGZ devices been recalled?
Yes: 33 product recalls across 19 recall events; the most recent began 2026-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LGZ
- Run a recall and safety report across every LGZ manufacturer
- Watch product code LGZ 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times