510(k) · Cleared
ClearedIsolette 8000 plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Sytems, Inc. · FMZ Incubator, Neonatal
Cleared on Apr 19, 2018 as substantially equivalent to K001242 (Hill-Rom Air-Shields, 2000) after a 276-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Apr 19, 2018
- Review
- 276 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001242 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001242 Isolette Infant Incubator, Model C2HSHill-Rom Air-Shields · 2000
- This deviceK172154 Isolette 8000 plusDraeger Medical Sytems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK243437 mOm Essential Incubator (ME1)Mom Incubators Limited · 2025
- Descendant · cites it directly · 0 of its ownK182977 Isolette 8000 PlusDraeger Medical Systems, Inc. · 2018
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 | K001242 | Isolette Infant Incubator, Model C2HS | Hill-Rom Air-Shields | 2000 | — |
| 0 (this device) | K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | 2018 | — |
| +1 | K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | 2025 | — |
| +1 | K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 FMZ? 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 FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K001242 | Isolette Infant Incubator, Model C2HSSummary page 4…II Legally Marketed Device Identification: Substantial equivalence is claimed to the legally marketed predicate; Isolette Infant Incubator, Model C2HS, K001242. Device Description: The Isolette 8000 plus is a device used to maintain environmental conditions suitable for neonates. The I… | 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 FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, 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 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Isolette® 8000 plus incubator is indicated for thermoregulation and controlling oxygen (optional), and humidity
(optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).
The Isolette® 8000 plus is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172154: Isolette 8000 plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172154
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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