510(k) · Cleared
ClearedSREE MRI Transport Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Imaging Research Dba Sree Medical Systems · FPL Incubator, Neonatal Transport
Cleared on Mar 3, 2017 as substantially equivalent to K062052 (Lmt Lammers Medical Technology GmbH, 2006) and 1 other predicate after a 233-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 3, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001019 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001019 TI500 Globe-Trotter Transport SystemHill-Rom Air-Shields · 2000 · Recalled
- 2 generations backK033565 LMT Nomag IC 1,5Lmt Lammers Medical Technology GmbH · 2003
- 1 generation backK062052 LMT Nomag IC 3.0Lmt Lammers Medical Technology GmbH · 2006
- This deviceK161918 SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001019 | TI500 Globe-Trotter Transport System | Hill-Rom Air-Shields | 2000 | 2 |
| −2 | 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 | — |
| 0 (this device) | K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017 | — |
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? (2)
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 |
|---|---|---|---|
| * | K062052 | LMT Nomag IC 3.0Summary page 4…on Number: 21 CFR 880.5410 Product Code: FPL Device Class: Class II Primary Predicate Device: K062052 LMT Nomag IC 3.0 Secondary Predicate Device: K033565 LMT Nomag IC 1.5 Device Description The SREE MRI Transport Incubat… | 2006 |
| * | K033565 | LMT Nomag IC 1,5Summary page 4…FPL Device Class: Class II Primary Predicate Device: K062052 LMT Nomag IC 3.0 Secondary Predicate Device: K033565 LMT Nomag IC 1.5 Device Description The SREE MRI Transport Incubator system consists of a MRI incubator, MRI trolley and backup… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.
The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7”).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161918: SREE MRI Transport Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161918
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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