510(k) · Cleared
ClearedIsolette Infant Incubator, Model C2000E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Manufacturing, Inc. · FMZ Incubator, Neonatal
Cleared on Aug 1, 2003 as substantially equivalent to K960980 (Air-Shields, Inc., 1996) after a 91-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 1, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960980 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960980 Isolette Infant IncubatorAir-Shields, Inc. · 1996
- This deviceK031387 Isolette Infant Incubator, Model C2000EHill-Rom Manufacturing, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960980 | Isolette Infant Incubator | Air-Shields, Inc. | 1996 | — |
| 0 (this device) | K031387 | Isolette Infant Incubator, Model C2000E | Hill-Rom Manufacturing, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K960980 | Isolette Infant IncubatorSummary page 1…General Hospital 21 CFR 862.1 13 Neonatal Incubator, ???, Class II Performance Standards: None applicable - Predicate Device: K960980 C2000 Isolette8 Infant Incubator Device Description The C2000e is an enhancement to the currently marketed C2000 Isolett… | 1996 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K960980.
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 | — |
What is it indicated for?
The Air Shields ISOLETTE@Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator. It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically…
Read the full statement (173 words)
The Air Shields ISOLETTE@Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.
It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE@to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, Ill, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.
This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.
This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031387: Isolette Infant Incubator, Model C2000E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031387
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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