Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Draeger Medical Systems, Inc. · Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
300 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025-01-17 | 57 | 0 |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024-08-01 | 181 | 0 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 | 221 | 0 |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023-10-17 | 148 | 0 |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023-05-30 | 118 | 0 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 | 547 | 0 |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022-02-01 | 476 | 1 |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021-12-09 | 528 | 0 |
| K200859 | Infinity M300 | Draeger Medical Systems, Inc. | 2020-08-28 | 149 | 1 |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | 2018-11-21 | 26 | 0 |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018-05-01 | 238 | 0 |
| K151860 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2015-09-02 | 56 | 2 |
| K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WOR | Draeger Medical Systems, Inc. | 2014-12-12 | 165 | 0 |
| K133175 | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | 2014-11-13 | 392 | 1 |
| K141565 | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | 2014-09-10 | 90 | 0 |
| K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 | Draeger Medical Systems, Inc. | 2013-04-11 | 27 | 0 |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | 2012-11-02 | 245 | 1 |
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW | Draeger Medical Systems, Inc. | 2012-03-22 | 90 | 4 |
| K113206 | NANOBLUTM 500 | Draeger Medical Systems, Inc. | 2012-02-17 | 108 | 0 |
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE | Draeger Medical Systems, Inc. | 2011-10-06 | 300 | 4 |
| K102968 | INFINITY CNAP SMARTPOD | Draeger Medical Systems, Inc. | 2011-02-18 | 135 | 0 |
| K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION | Draeger Medical Systems, Inc. | 2010-03-08 | 89 | 4 |
| K082888 | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 | Draeger Medical Systems, Inc. | 2008-11-26 | 57 | 0 |
| K073113 | INFINITY PICCO POD, MODEL MS16734 | Draeger Medical Systems, Inc. | 2008-01-03 | 59 | 0 |
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000 | Draeger Medical Systems, Inc. | 2007-06-04 | 96 | 6 |
| K061379 | INFINITY TELESMART TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2007-02-16 | 275 | 0 |
| K061329 | INFINITY MASIMO SET SP02 POD | Draeger Medical Systems, Inc. | 2006-07-07 | 56 | 0 |
| K060223 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2006-04-12 | 72 | 0 |
| K060039 | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATI | Draeger Medical Systems, Inc. | 2006-04-12 | 96 | 1 |
| K060254 | MODIFICATION TO INFINITY EXPLORER | Draeger Medical Systems, Inc. | 2006-04-04 | 62 | 0 |
| K053484 | INFINITY GAMMA / GAMMAXL, INFINITY VISTA | Draeger Medical Systems, Inc. | 2006-02-22 | 69 | 1 |
| K051658 | INFINITY ALPHA | Draeger Medical Systems, Inc. | 2005-11-16 | 148 | 0 |
| K051628 | INFINITY MONITORS WITH SCIO MODIFICATIONS | Draeger Medical Systems, Inc. | 2005-07-20 | 30 | 0 |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTO | Draeger Medical Systems, Inc. | 2005-04-29 | 11 | 0 |
| K042904 | INFINITY KAPPA XLT | Draeger Medical Systems, Inc. | 2005-02-18 | 120 | 0 |
| K043439 | INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPP | Draeger Medical Systems, Inc. | 2005-02-18 | 66 | 0 |
| K043549 | INFINITY GATEWAY SUITE, VF4 | Draeger Medical Systems, Inc. | 2005-01-21 | 29 | 0 |
| K042656 | INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 | Draeger Medical Systems, Inc. | 2004-10-06 | 8 | 0 |
| K042003 | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | 2004-09-01 | 37 | 0 |
| K033957 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODEL | Draeger Medical Systems, Inc. | 2004-05-14 | 144 | 0 |
| K041087 | INFINITY GAMMA | Draeger Medical Systems, Inc. | 2004-05-12 | 16 | 0 |
| K040945 | MODIFICATION TO INFINITY EXPLORER | Draeger Medical Systems, Inc. | 2004-05-12 | 30 | 0 |
| K040188 | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | Draeger Medical Systems, Inc. | 2004-04-14 | 77 | 0 |
| K033694 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS | Draeger Medical Systems, Inc. | 2004-03-22 | 119 | 0 |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROT | Draeger Medical Systems, Inc. | 2004-03-09 | 92 | 0 |
| K033600 | INFINITY GAMMAXL | Draeger Medical Systems, Inc. | 2003-12-11 | 27 | 0 |
| K032537 | DRAEGER MICRO2+ AND MASIMO MINISAT | Draeger Medical Systems, Inc. | 2003-11-25 | 99 | 0 |
| K033305 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2003-10-31 | 17 | 0 |
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