Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LGZ — Predicate Candidate Screening
75 FDA 510(k) clearances under this product code; the 50 most recent screened below.
126 daysmedian FDA review time
366 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260988 | °M Warmer System with °M Station | Mequ A/S | 2026-04-24 | 30 | 0 |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | 2025-11-18 | 90 | 0 |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | 2025-09-04 | 90 | 0 |
| K232107 | °M Warmer System | Mequ A/S | 2024-05-31 | 322 | 0 |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023-06-05 | 740 | 0 |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fl | Quality IN Flow , Ltd. | 2022-12-08 | 546 | 0 |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid | Smisson-Cartledge Biomedical, LLC | 2022-08-12 | 715 | 0 |
| K213191 | S-Line | Barkey GmbH & Co. KG | 2022-05-24 | 237 | 0 |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | 2019-10-18 | 52 | 0 |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | 2019-03-05 | 340 | 0 |
| K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019-01-28 | 209 | 0 |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2018-04-27 | 98 | 0 |
| K171215 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-09-27 | 155 | 0 |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-04-20 | 112 | 0 |
| K161613 | Hang&Go PAC | Rand S.R.L. | 2016-12-28 | 201 | 0 |
| K150404 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2016-06-23 | 491 | 0 |
| K152208 | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | 2015-09-02 | 26 | 3 |
| K150484 | Penguin In-Line Warmer | Creche Innovations | 2015-07-09 | 135 | 0 |
| K132202 | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CAB | Enthermics Medical Systems, Inc. | 2013-12-06 | 143 | 0 |
| K131519 | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2013-11-06 | 162 | 0 |
| K132110 | NATUS WARMETTE BLANKET AND DUAL CABINETS | Natus Nicolet Ireland, Ltd. | 2013-10-03 | 86 | 0 |
| K130867 | ENFLOW IV FLUID WARMER INSULATED STRAP | Vital Signs, Inc., A GE Healthcare Company | 2013-06-14 | 78 | 2 |
| K122449 | ENTERAL NUTRITION WARMER | Acacia, Inc. | 2013-06-13 | 304 | 0 |
| K121775 | ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW | Vital Signs, Inc., A GE Healthcare Company | 2012-11-28 | 163 | 0 |
| K121198 | BW685, BW685S | Biegler GmbH | 2012-07-12 | 84 | 0 |
| K120026 | PERFORMER HT/ HANG&GO HT BASIC | Rand S.R.L. | 2012-05-08 | 126 | 0 |
| K120860 | INFU BOX TYPE 0412A | Medical Rescue Equipment Holding AS | 2012-05-08 | 47 | 0 |
| K112702 | IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS | Imperial Surgical , Ltd. | 2012-03-29 | 195 | 0 |
| K102900 | HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM | Hei, Inc. | 2012-03-21 | 538 | 0 |
| K112902 | ENFLOW IV FLUID WARMER | Vital Signs, Inc. | 2012-03-14 | 162 | 0 |
| K111870 | AMSCO WARMING CABINET | STERIS Corporation | 2011-07-29 | 28 | 0 |
| K110769 | AMSCO WARMING CABINET | STERIS Corporation | 2011-06-03 | 77 | 0 |
| K103801 | HYPOTHERMX INTRAVENOUS FLUID WARMER | Emit Corporation | 2011-05-20 | 143 | 0 |
| K091336 | IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IV | Enthermics Medical Systems, Inc. | 2010-05-07 | 366 | 0 |
| K092366 | TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE | Thermal Therapeutic Systems, Inc. | 2010-03-04 | 211 | 0 |
| K092823 | AMSCO WARMING CABINET | STERIS Corporation | 2009-12-18 | 95 | 0 |
| K090089 | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2009-02-12 | 29 | 0 |
| K082765 | ASTOFLO PLUS | Stihler Electronic GmbH | 2008-12-18 | 87 | 0 |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | Arizant Healthcare, Inc. | 2008-10-06 | 61 | 0 |
| K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NOR | Smiths Medical Asd, Inc. | 2008-06-02 | 308 | 0 |
| K073363 | THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 30 | Paladin Biomedical Corporation | 2008-03-20 | 111 | 0 |
| K062644 | FLEXWARMER, MODELS KZ-1 AND KZ-2 | Merlyn Associates, Inc. | 2007-09-11 | 370 | 0 |
| K070654 | HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2007-06-08 | 91 | 0 |
| K060851 | SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, T | The Smithworks Company | 2006-12-22 | 269 | 0 |
| K052055 | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 | Smisson-Cartledge Biomedical, LLC | 2006-10-26 | 454 | 3 |
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | Arizant Healthcare, Inc. | 2006-06-26 | 81 | 1 |
| K060537 | EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE | Enginivity, LLC | 2006-06-08 | 100 | 6 |
| K041839 | 8NONE | Medical Solutions, Inc. | 2005-02-15 | 222 | 0 |
| K032778 | LARGE VOLUME FLUID RESERVOIR | Belmont Instrument Corp. | 2003-09-22 | 14 | 0 |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | Belmont Instrument Corp. | 2003-09-16 | 18 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda