510(k) · Cleared
ClearedLMT Nomag IC 1,5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lmt Lammers Medical Technology GmbH · FPL Incubator, Neonatal Transport
Cleared on Nov 21, 2003 as substantially equivalent to K001019 (Hill-Rom Air-Shields, 2000) after a 9-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Nov 21, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001019 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001019 TI500 Globe-Trotter Transport SystemHill-Rom Air-Shields · 2000 · Recalled
- This deviceK033565 LMT Nomag IC 1,5Lmt Lammers Medical Technology GmbH · 2003
- Descendant · cites it directly · 1 of its ownK062052 LMT Nomag IC 3.0Lmt Lammers Medical Technology GmbH · 2006
- Descendant · cites it directly · 0 of its ownK161918 SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001019 | TI500 Globe-Trotter Transport System | Hill-Rom Air-Shields | 2000 | 2 |
| 0 (this device) | K033565 | LMT Nomag IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003 | — |
| +1 | K062052 | LMT Nomag IC 3.0 | Lmt Lammers Medical Technology GmbH | 2006 | — |
| +1 | K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPL device
- #1 K220742 NxtGen Infant Transport Incubatorscore 4.3 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001019 | TI500 Globe-Trotter Transport SystemSummary page 1…. 880.5410 Class 2 Propietary Name LMT nomag IC 1,5 Performance Standard: 1EC 60601-2-20 IEC 60601-1 1ISO 10993 Legally marketed device Hill-Rom Air-Shields T1 500 K#001019 510(k) Submission LMT nomag IC 1,5 03-00-510k_Summary-V04.doc Sec.3-page1/3 23. Jun. 2003 Sec. 3 510(k) Summary… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FPL
148in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPL
No recall names FPL since 2007.
Adverse event reports per year · FPL
3in 2024
MAUDE reports naming product code FPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 4 | 148 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
LMT nomag IC 1,5 is an infant incubator system for temporary use during MR-imaging in clinical environments and in combination with a suitable trolley for intra hospital transport.
LMT nomag IC 13 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 Ibs) and a maximum body length of 55 cm (21.7 inches).
LMT nomag IC 1.5 is suitable for MR scanner of field strengths up to 1ST.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033565: LMT Nomag IC 1,5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033565
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026