Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMT — Predicate Candidate Screening
92 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
290 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025-01-17 | 57 | 0 |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023-05-30 | 118 | 0 |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 | 114 | 5 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021-02-12 | 241 | 3 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-T | Deroyal Industries, Inc. | 2020-04-02 | 55 | 0 |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | 2020-01-21 | 237 | 0 |
| K173516 | NuBorne Infant Warmer | International Biomedical | 2018-08-17 | 276 | 0 |
| K123309 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | 2013-02-05 | 104 | 9 |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | 2012-11-02 | 245 | 1 |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 | 64 | 5 |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | 2012-09-14 | 105 | 0 |
| K120937 | SUNFLOWER WARNER | Atom Medical Corporation | 2012-07-06 | 100 | 0 |
| K102227 | INFA WARMER I | Atom Medical Corporation | 2011-01-21 | 165 | 0 |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 | 23 | 1 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2009-04-16 | 30 | 1 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA | Ohmeda Medical | 2007-08-27 | 24 | 0 |
| K070377 | GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2007-07-11 | 153 | 2 |
| K060461 | V-505 INFA WARMER | Atom Medical, Inc. | 2006-04-28 | 65 | 0 |
| K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | International Hospital Supply Co. | 2003-12-17 | 79 | 0 |
| K020966 | RPI REPLACEMENT HEATING ELEMENTS | Replacement Parts Industries, Inc. | 2002-06-13 | 80 | 0 |
| K020219 | RPI SKIN OR AIR TEMPERATURE PROBE | Replacement Parts Industries, Inc. | 2002-04-12 | 80 | 0 |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700, | National Custom Ent., Inc. | 2001-09-10 | 56 | 0 |
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARM | Hill-Rom Air-Shields | 2000-11-17 | 23 | 1 |
| K002355 | ATOM INFA WARMER V-505 | Atom Medical Corp | 2000-10-10 | 69 | 0 |
| K971366 | INCUWARMER | Hill-Rom, Inc. | 1998-01-05 | 266 | 0 |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, | Fisher & Paykel Electronics , Ltd. | 1997-10-30 | 86 | 0 |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | Drager, Inc. | 1997-10-03 | 186 | 0 |
| K970686 | ACCUTEMP-PROBE | Kentec Medical, Inc. | 1997-08-25 | 181 | 0 |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT | Fisher & Paykel Electronics , Ltd. | 1997-07-28 | 81 | 0 |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL | Fisher & Paykel Electronics , Ltd. | 1997-07-16 | 86 | 1 |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | Fisher & Paykel Electronics , Ltd. | 1997-05-07 | 92 | 2 |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1 | Hill-Rom, Inc. | 1997-04-03 | 85 | 0 |
| K964401 | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DT | Ludlow Technical Products | 1997-02-06 | 94 | 0 |
| K950422 | FIRST TOUCH DISPOSABLES TEMPERATURE PROBES | First Touch Disposables, Inc. | 1997-01-23 | 721 | 0 |
| K963058 | INFANT WARMER SYSTEM | Ohmeda Medical | 1996-10-01 | 56 | 1 |
| K960080 | ACCUTEMP PROBE | Kentec Medical, Inc. | 1996-05-01 | 111 | 0 |
| K952801 | TEMPERATURE PROBE-TP250 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952800 | TEMPERATURE PROBE-TP150 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952805 | TEMPERATURE PROBE-TP550 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952803 | TEMPERATURE PROBE-TP350 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952807 | TEMPERATURE PROBE-TP650 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952804 | TEMPERATURE PROBE-TP450 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K953489 | DRAGER INFANT RADIANT WARMERN RH600 | Drager, Inc. | 1996-02-09 | 199 | 0 |
| K950143 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE | Astral, Ltd. | 1995-09-25 | 255 | 0 |
| K946005 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE | Astral, Ltd. | 1995-09-25 | 290 | 0 |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | Air-Shields, Inc. | 1995-05-03 | 427 | 0 |
| K942905 | DISPOSABLE TEMPERATURE PROBE COVER | Arbo Medical, Inc. | 1995-02-27 | 251 | 0 |
| K942904 | STABILET | Hill-Rom, Inc. | 1994-09-16 | 87 | 0 |
| K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE | U.S. Medical Corp. | 1994-07-05 | 280 | 0 |
| K935609 | 4002 INFANT SCALE FOR INCUBATORS AND WARMERS | Scale-Tronix, Inc. | 1994-07-01 | 224 | 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