510(k) · Cleared
ClearedIsolette Infant Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air-Shields, Inc. · FMZ Incubator, Neonatal
Cleared on Jul 30, 1996 after a 141-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 30, 1996
- Review
- 141 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK960980 Isolette Infant IncubatorAir-Shields, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK971366 IncuwarmerHill-Rom, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
- Descendant · cites it directly · 0 of its ownK071977 Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK031387 Isolette Infant Incubator, Model C2000EHill-Rom Manufacturing, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K971366IncuwarmerHill-Rom, Inc. · 1998 · cites it directly2descendants
- K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000 · cites it directly1descendant
- K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008 · cites it directly0descendants
- K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006 · 2 generations on0descendants
- K031387Isolette Infant Incubator, Model C2000EHill-Rom Manufacturing, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960980 | Isolette Infant Incubator | Air-Shields, Inc. | 1996 | — |
| +1 | K971366 | Incuwarmer | Hill-Rom, Inc. | 1998 | — |
| +1 | K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | 2000 | — |
| +1 | K071977 | Tarry Medical Temperature Probes | Tarry Medical Products, Inc. | 2008 | — |
| +2 | K053399 | Versalet 7700 Care Center | Draeger Medical Infant Care, Inc. | 2006 | — |
| +1 | K031387 | Isolette Infant Incubator, Model C2000E | Hill-Rom Manufacturing, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K971366 (Hill-Rom, Inc., 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K960980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960980: Isolette Infant Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960980
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026