510(k) · Cleared
ClearedLMT Nomag IC 3.0
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 Jul 31, 2006 as substantially equivalent to K033565 (Lmt Lammers Medical Technology GmbH, 2003) after an 11-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jul 31, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001019 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001019 TI500 Globe-Trotter Transport SystemHill-Rom Air-Shields · 2000 · Recalled
- 1 generation backK033565 LMT Nomag IC 1,5Lmt Lammers Medical Technology GmbH · 2003
- This deviceK062052 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 1 of 1 · See all- K161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001019 | TI500 Globe-Trotter Transport System | Hill-Rom Air-Shields | 2000 | 2 |
| −1 | K033565 | LMT Nomag IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033565 | LMT Nomag IC 1,5Summary page 1…1-2-20: 1996 lEC 60601 -1 (Ed.2): 1995 ISO 10993: 1997 Legally marketed device LMVT nomag IC 1.5 K#033565 Reason for 51 0(k): extended indications for use 51 0(k) TPR Submission LMVT nomag IC 3.0 05-… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161918 | SREE MRI Transport Incubator | 2017 | 0 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K161918 (Advanced Imaging Research Dba Sree Medical Systems, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033565.
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?
The LMT nomag IC 3.0 MR-incubator is an infant incubator system for temporary use during MR-imaging in clinical environments provided with b suitable trolley for intra hospital transport.
The LMT nomag IC 3.0 MR-incubator provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4.5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).
The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.OT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062052: LMT Nomag IC 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062052
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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